MAY 2010

WEEK ENDING MAY 29

PRODUCT Zyrtec Itchy Eye Drops (ketotifen fumarate) ophthalmic solution, 0.025%, 0.17 Fl oz (5 mL) bottle, NDC 50580-732-05, UPC 30045-208-057. 

CODE

Lot numbers: JE2425, JE2425A, JE2426, JE2427, JE5608, JE6160, JE6160A, JG5286, JG5286A, JG5286B, JG7349, JJ6419, and JJ6422

RECALLING FIRM

McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, 

REASON Failed PH Specifications: out of specification (OOS) results for pH during stability testing.

VOLUME OF PRODUCT IN COMMERCE 1,183,614 bottles

DISTRIBUTION Nationwide

 

PRODUCT Rifampin USP, lyophilized powder for injection, 600 mg, sterile glass vial packaged in an individual carton, Rx only, NDC 55390-123-01. 

CODE Lot #1639562, Exp 01/11

RECALLING FIRM/MANUFACTURER

Ben Venue Laboratories Inc., Bedford, OH,

REASON Lack of assurance of sterility: Non-viable particulate (NVP) monitoring results exceeded action limits for approximately 40% of the filling operation which was not detected or corrected during the fill.

VOLUME OF PRODUCT IN COMMERCE 20,865 vials

DISTRIBUTION Nationwide

 

PRODUCT

1) Fisiolin (sodium chloride), sterile nasal drops, supplied in 0.5 fl oz (15 mL) bottles packaged in individual boxes, NDC 66502-900-15. 

2) Camolyn, Homeopathic (Matricaria chamomilla tincture HPUS 3X, Hamamelis virginiana tincture HPUS 3X), eye drops, supplied in 0.5 fl oz (15 mL) bottles, NDC 66502-415-15. 

3) Camolyn-A (Naphazoline hydrochloride 0.025%, Pheniramine Maleate 0.3%), eye drops, supplied in 0.5 fl oz (15 mL) bottles packaged in individual boxes, NDC 66502-320-15. 

4) Camolyn Plus (Naphazoline Hydrochloride 0.012%, Matricaria Chamomile 0.2%, Virginian Hamamelis 0.1%), eye drops, supplied in 0.5 fl oz (15 mL) bottles packaged in individual boxes, NDC 66502-510-15. 

5) Camolyn Refresh (Dextran 70%, Hydroxypropyl Methylcellulose 0.3%), eye drops, supplied in 0.5 fl oz (15 mL) bottles packaged in individual boxes, NDC 66502-220-15. 

CODE

1) All Lots: 028659, Exp 03/2011;

2) All Lots: 049036, Exp 05/2011; 087934, Exp 08/2009;

3) All Lots: 057063, Exp 5/2009; 058962, 04/2010; 106606, Exp 10/2008; 099487, Exp 09/2011;

4) All Lots: 037691, Exp 3/2010; 097420, Exp 10/2010;

5) All Lots: 16636, Exp 11/2009; 107610, Exp 11/2010

RECALLING FIRM/MANUFACTURER

US Recalling Firm: Oftalmi Corp., Hallandale Beach, FL, 

Manufacturer: Laboratorios L.O. Oftalmi, C.A., Caracas, Venezuela. 

REASON Lack of Assurance of Sterility: Products were manufactured in conditions that compromised the sterility of the products.

VOLUME OF PRODUCT IN COMMERCE 45,842 bottles

DISTRIBUTION Nationwide

Blacksmith Brands Announces Recall Of Four PediaCare Children's Products

Blacksmith Brands, Inc. is recalling all lots of four children's products in the PediaCare line. These products are sold exclusively in the United States. 

The four PediaCare items involved in the recall are:

  1.  
    1. PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
    2. PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
    3. PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
    4. PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

Tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant.

Consumers with questions may contact Blacksmith Brands on Friday, May 28th 5pm – 9pm EST; Saturday-Monday 9am-5pm EST; and normal business hours thereafter at (888) 474-3099. More information is available at blacksmithbrands.com.

Hospira Announces an Expansion Recall of Certain Lots of Liposyn™ and Propofol That May Contain Particulate Matter 

Hospira, Inc. (NYSE: HSP) is  expanding its March 31, 2010, recall of Propofol Injectable Emulsion 1% and Liposyn™ (Intravenous Fat Emulsion) products which include Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30% to the consumer or user level. Hospira is conducting the recall because some of the containers may contain particulate matter. The particulate is primarily made up of sub-visible inert stainless steel particles.

The affected lot numbers are shown in the table below:

Product All lot numbers beginning with: Expiration date range
Propofol 66; 67; 68; 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, 85 June 1, 2010
   through
January 1, 2012
Liposyn 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, 85 June 1, 2010
   through
July 1, 2011

The expanded recall affects additional lots of propofol and Liposyn distributed during a wider timeframe to capture all product that might currently be in customer inventories.

The affected lots of Liposyn were distributed between December 2008 and April 2010. The affected lots of propofol were distributed between March 2008 and April 2010. These products were distributed in the United States, Barbados, Canada, Chile, South Korea, Australia, Dominican Republic, Japan, Philippines, Puerto Rico, Uruguay, and the U.S. Virgin Islands. These products are packaged in glass containers. Propofol containers come in 20 mL, 50 mL and 100 mL sizes. Liposyn containers come in 250 mL and 500 mL sizes. 

Anyone with an existing inventory should stop use and distribution and quarantine the product immediately and call Stericycle at 1-877-884-7835 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

WEEK ENDING MAY 22

PRODUCT 
1) Propofol Injectable Emulsion 1%, 10 mg/mL, a) 5 Units x 20 mL vials per box NDC 0409-4699-30; b) 5 Units x 20 mL vials per box (Amerinet Choice) NDC 0409-4699-61;  c) 20 Units x 50 mL vials per box NDC 0409-4699-33; d) 10 Units x 100 mL vials per box NDC 0409-4699-24; e) 10 Units x 100 mL vials per box (Amerinet Choice) NDC 0409-4699-63; Rx only. 

2) Liposyn II Intravenous Fat Emulsion, 10%, 500 mL bottle, Rx only, NDC 0409-9786-03.

3) Liposyn II Intravenous Fat Emulsion, 20%, 500 mL bottle, Rx only, NDC 0409-9789-03. 

4) Liposyn III Intravenous Fat Emulsion, 10%, a) 250 mL bottle, NDC 0409-9790-02; b) 500 mL bottle, NDC 0409-9790-03; Rx only. 

5) Liposyn III Intravenous Fat Emulsion, 20%, a) 250 mL bottle, NDC 0409-9791-02; b) 500 mL bottle, NDC 0409-9791-03; Rx only. 

6) Liposyn III Intravenous Fat Emulsion, 30%, 500 mL bottle, Rx only, NDC 0409-6892-03.
CODE
1) a) Lot #: 79-814-DJ, 79-816-DJ, 79-817-DJ, 79-818-DJ, 79-820-DJ, 79-821-DJ, 79-823-DJ, 79-824-DJ, 79-825-DJ, 79-827-DJ, and 79-872-DJ, Exp 07/01/11; Lot #: 80-006-DJ, 80-009-DJ, 80-011-DJ, 80-012-DJ, 80-016-DJ, 80-017-DJ, 80-020-DJ, 80-021-DJ, 80-022-DJ, 80-025-DJ, 80-026-DJ, 80-028-DJ, 80-103-DJ and 80-104-DJ and 80-108-DJ, Exp 08/01/11; b) Lot #: 80-055-DJ, Exp 08/01/11; c) Lot #: 79-884-DJ, 79-885-DJ, 79-886-DJ, 79-892-DJ, 79-894-DJ, 79-896-DJ, 79-898-DJ, 79-899-DJ, 79-901-DJ, 79-902-DJ, 79-903-DJ, 79-904-DJ and 79-906-DJ, Exp 07/01/11; d) Lot #: 79-842-DJ, 79-843-DJ, 79-844-DJ, 79-873-DJ, 79-874-DJ, 79-847-DJ, 79-848-DJ, 79-849-DJ, 79-850-DJ, 79-851-DJ, 79-854-DJ, 79-855-DJ, 79-856-DJ, 79-861-DJ, 79-863-DJ, 79-864-DJ, 79-865-DJ, 79-867-DJ, 79-868-DJ, 79-869-DJ, 79-870-DJ, 79-871-DJ, 79-910-DJ, and 79-911-DJ, Exp 07/01/11; Lot #: 80-118-DJ, 80-119-DJ, 80-120-DJ and 80-121-DJ, Exp 08/01/11; e) Lot #: 79-840-DJ and 79-841-DJ, Exp 07/01/11; Lot #: 80-111-DJ, 80-112-DJ and 80-113-DJ, Exp 08/01/11;

2) Lot #: 79-772-DW, 79-773-DW, 79-774-DW, 79-775-DW, 79-776-DW, 79-777-DW, and 79-778-DW, Exp 01/01/11; Lot #: 80-981-DW, 80-982-DW, 80-983-DW, 80-984-DW, 80-986-DW, 80-989-DW, 80-990-DW, 80-991-DW, 80-992-DW and 80-993-DW, Exp 02/01/11;

3) Lot #: 79-787-DW, 79-788-DW, 79-789-DW, 79-790-DW, 79-791-DW, 79-792-DW, and 79-793-DW, Exp 01/01/11; Lot #: 80-995-DW, 80-996-DW, 80-997-DW and 80-998-DW, Exp 02/01/11;

4) a) Lot #: 79-733-DW, Exp 01/01/11; Lot #: 80-912-DW, and 80-913-DW, Exp 02/01/11; b) Lot #80-925-DW, 80-926-DW, 80-928-DW, 80-929-DW, 80-930-DW, 80-931-DW, 80-932-DW and 80-933-DW, Exp 02/01/11;

5) a) Lot #: 79-736-DW, 79-737-DW, 79-738-DW, 79-739-DW, 79-740-DW, 79-741-DW, 79-742-DW, and 79-743-DW, Exp 01/01/11; Lot #: 80-916-DW, 80-917-DW, 80-918-DW, and 80-919-DW, Exp 02/01/11; b) Lot #: 79-746-DW, 79-747-DW, 79-748-DW, 79-749-DW, 79-750-DW, 79-751-DW, 79-752-DW, 79-753-DW, 79-754-DW, 79-755-DW, and 79-756-DW, Exp 01/01/11; Lot #: 80-940-DW, 80-941-DW, 80-942-DW, 80-943-DW, 80-944-DW, 80-945-DW, 80-946-DW, 80-947-DW, 80-948-DW, 80-949-DW, 80-950-DW, 80-951-DW and 80-952-DW, Exp 02/01/11;

6) Lot #: 79-761-DW, and 79-762-DW, Exp 01/01/11; Lot #: 80-970-DW, 80-972-DW, 80-973-DW, 80-974-DW, 80-975-DW, 80-976-DW, 80-977-DW and 80-978-DW, Exp 02/01/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, 
Manufacturer: Hospira, Inc., Clayton, NC. 
REASON Presence of Particulate Matter: Particle substance observed in the bottom of filled product retains samples.
VOLUME OF PRODUCT IN COMMERCE 1,322,403 vials/bottles
DISTRIBUTION Nationwide and Canada

PRODUCT 
1) Hyaluronidase PF, 150 units/mL Injection solution, 10 mL clear glass vial with red cap, No Preservatives, Single use vial, Rx only, used for ophthalmic surgeries. Affected product was dispensed beginning 07/25/2009. Product was distributed domestically to hospital pharmacies and ophthalmic surgical clinics. Drug ID #15859: Drug ID#16102; Drug ID#15927. 

2) Hyaluronidase PF, 160 units/mL Injection solution, 10 mL clear glass vial with red cap, No Preservatives, Single use vial, Rx only, Compounded for Physician/Hospital used for ophthalmic surgeries. Affected product was dispensed beginning 07/25/2009. Product was distributed domestically to hospital pharmacies and ophthalmic surgical clinics. Drug ID#15824. 

3) Hyaluronidase PF, 1500 units/mL Injection solution, 1 mL clear glass vial with red cap, No Preservatives, Single use vial, Rx only, used for ophthalmic surgeries. Affected product was dispensed beginning 07/25/2009. Product was distributed domestically to hospital pharmacies and ophthalmic surgical clinics. Drug ID# 16032. 
CODE
1) Lot #s (Rx #s) - 2306460, 2306462, 2306463, 2306464, 2306465, 2307026, 2303427, 2301103, 2300720, 2306206, 2307529, 2305815, 2304707, 2308456, 2308458, 2309625, 2301008, 2304412, 2306431, 2306644; Lot #s (Rx #s)- 2302326, 2302015, 2303424, 2301305, 2301308, 2301592, 2302657, 2301804, 2303437; Lot# (Rx#)- 2305638;

2) Lot #s (Rx #s) - 2297000, 2297002, 2296999, 2296998, 2296996, 2298500, 2298378, 2298894;

3) Lot #s (Rx #s) - 2306632, 2306209
RECALLING FIRM/MANUFACTURER
AnazaoHealth Corp., Tampa, FL, 
REASON Product is being recalled due to reports of adverse events such as lid swelling, periorbital cellulitis and chemosis.
VOLUME OF PRODUCT IN COMMERCE 1242 mL (126 vials)
DISTRIBUTION AL, CO, FL, IL, OH, TX, VA

PRODUCT 
1) Ketorolac Tromethamine Injection, USP, 30 mg/mL, 25-count 1 mL Single Dose Vials per carton, Rx Only, NDC 0517-0801-25. 

2) Ketorolac Tromethamine Injection, USP, 15 mg/mL, 25-count 1 mL Single Dose Vials per carton, Rx Only, NDC 0517-0601-25. 

3) Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 25-count 2 mL Single Dose Vials per carton, Rx only; NDC 0517-0902-25. 
CODE
1) Lots 8512 (exp. 1/31/2010), 8534 (exp. 2/28/2010), 8538 (exp. 2/28/2010), 8626 (exp. 3/31/2010), 8708 (exp. 4/30/2010), 8721 (exp. 4/30/2010), 9017 (exp. 11/30/2009), 9025 (exp. 11/30/2009), 9045 (exp. 11/30/2009), 9054 (exp. 11/30/2009), 9161 (exp. 1/31/2010), 9192 (exp. 1/31/2010), 9221 (exp. 2/28/2010), 9235 (exp. 2/28/2010), 9261 (exp. 2/28/2010), 9314 (exp. 3/31/2010), 9341 (exp. 3/31/2010), 9395 (exp. 4/30/2010), 9463 (exp. 5/31/2010), 9484 (exp. 5/31/2010);

2) Lots 8513 (exp. 1/31/2010); 8725 (exp. 4/30/2010), and 9279 (exp. 10/31/2010);

3) Lots 8514 (exp. 1/31/2010), 9021 (exp. (11/30/2009), 9079 (exp. 12/09/2009), 9102 (exp. 12/31/2009), 9238 (exp. 2/28/2010), 9466 (exp. 5/31/2010)
RECALLING FIRM/MANUFACTURER Luitpold Pharmaceuticals, Inc., Shirley, NY, 
REASON Presence of Particulate Matter: Firm observed particles in some retain vials of Ketorolac Tromethamine Injection, USP, 30 mg/mL & 15mg/mL.
VOLUME OF PRODUCT IN COMMERCE 5,029,650 vials
DISTRIBUTION Nationwide and Abu Dhabi

PRODUCT 
1) Firmagon (degarelix) for injection; 80 mg, 1 vial of 80 mg per carton; Rx only; NDC 55566-8301-1. 

2) Firmagon (degarelix) for injection; 240 mg (NDC 5566-8401-1), 2 vials of 120 mg (NDC 55566-8401-0) per carton; Rx only.
CODE
1) Lot: CC0417A, CC0417C, CC0417D, CC0417H, CC0417I, Exp 08/11; CC0032A, CD0032F, CD0032I, Exp 12/11; CD0173A, CD0173B, Exp 03/12;

2) Lot: CC0558A, CC0558B, CC0559B, CC0559C, Exp 10/11; CD0172B, CD0172D, Exp 03/12; CD0255A, CD0355D, Exp 04/12; CD0342E, Exp 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, 
Manufacturer: Rentschler Biotechnologie Gmbh & Co. KG, Laupheim, Germany. 
REASON Lack of Assurance of Sterility: A small number of defective containers (reject vials) were introduced into commercial distribution.
VOLUME OF PRODUCT IN COMMERCE 15,689 cartons
DISTRIBUTION Nationwide

PRODUCT 
1) GlipiZIDE and Metformin HCL Tablets 2. 5 mg/250 mg; 100 count bottle, Rx only; NDC # 0781-5304-01. 

2) GlipiZIDE and Metformin HCL Tablets 2. 5 mg/500 mg; 100 count bottle, Rx only, NDC # 0781-5305-01. 

3) GlipiZIDE and Metformin HCL Tablets 5 mg/500 mg, 100 count bottle, Rx only. NDC # 0781-5306-01. 
CODE
1) Lot/ Exp date, 100606 4/11, 102466 10/11;

2) Lot / Exp date, CPI870 8/10, CPB931 1/11, 100387 3/11, 100824 5/11, 101101 5/11, 101651 7/11, 102482 10/11, 102483 10/11;

3) Lot/ Exp date, CPK825 10/10, CPB914 1/11, CPB915 1/11, 100353, 3/11 100354 3/11, 100573 3/11, 100602 3/11, 100939 5/11, 101096 5/11, 101097 5/11, 101652 7/11, 101653 7/11, 102484 10/11, 102486 10/11 102485 10/11
RECALLING FIRM/MANUFACTURER Corepharma LLC, Middlesex, NJ, 
REASON Tablets have the potential to contain metal particulates.
VOLUME OF PRODUCT IN COMMERCE 163,255 bottles
DISTRIBUTION Nationwide

PRODUCT 
1) Glyburide (micronized) and Metformin HCl tablets, 1.25 mg/250 mg, 100-count bottle NDC 0781-5170-01; 500-count bottle NDC 0781-5170-05; Rx only.

2) Glyburide(micronized) and Metformin HCL Tablets; 2.5 mg/500 mg,100 count bottle NDC 0781-5171-01, 2.5 mg/500 mg, 500 count bottle NDC 0781-5171-05, Rx only

3) Glyburide(micronized) and Metformin HCL Tablets; 5 mg/500 mg, 100 count bottle, NDC 0781-5172-01, 5 mg/500 mg, 500 count bottle NDC 0781-5172-05, Rx only. CODE
1) Lot /Exp. Date, CPI869 8/10, CPK819A 10/10, CPB968A 2/11, 100980 5/11 101423B 6/11, CPK819B 10/10, CPB968B 1/11, 101423A 6/11;

2) Lot /Exp. Date, CPI812 8/10, CPK818 10/10, CPK829 10/10, CPA961 12/10, CPA962 12/10, CPB939 1/11, CPB940 1/11, CPB941 1/11, CPB955 2/11, CPB956 2/11, 100278 2/11, 100279 2/11, 100280 2/11, 100657 4/11, 100658 4/11, 100925 5/11, 100926 5/11, 101098 5/11, 101099 5/11, 101100 5/11, 101419 6/11, 101420 6/11, 101931 9/11, CPK816 10/10 CPK817 10/10, CPK830 10/10, CPL801 11/10, CPB942 1/11;

3) Lot / Exp. Date, CPK821C 10/10, 100281 2/11, 101564 7/11, CPK832B 10/10 CPL802B 11/10. NDC# 0781-5172-05 (500 count), Lot / Exp. CPK822 10/10 CPK823 10/10, CPK832 10/10, CPL802 11/10, CPL803 11/10, CPL804 11/10
RECALLING FIRM/MANUFACTURER Corepharma Llc, Middlesex, NJ, 
REASON Tablets have the potential to contain metal particulates.
VOLUME OF PRODUCT IN COMMERCE 223,111 bottles
DISTRIBUTION Nationwide

Sagent Pharmaceuticals Initiates a Recall of All Lots of Metronidazole Injection, USP 500 mg/100 mL 

Sagent Pharmaceuticals, Inc. is recalling all lots of metronidazole injection, USP 500mg / 100mL (NDC number 25021-131-82) manufactured by Claris Lifesciences and distributed by Sagent. The lot numbers being recalled are: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019, which were distributed to hospitals, wholesalers and distributors nationwide from February through May 2010. Metronidazole injection, USP is an intravenous antimicrobial product used to treat infections and is supplied in a single dose plastic container.

Sagent has initiated this recall to the user level due to the discovery of non-sterility in two lots of metronidazole injection. 

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.SagentPharma.com. 

Any questions about returning unused product should be directed to the customer call center at (866) 946-4679 M-F 8am-7pm CST. Healthcare workers who have medical questions about metronidazole injection may contact Sagent Medical Affairs (866-625-1618 option 3).  

WEEK ENDING MAY 15

HYLENEX Recall

Baxter International Inc. (NYSE:BAX) is recalling manufactured lots of HYLENEX recombinant (hyaluronidase human injection) due to instances of particulate matter observed in a limited number of HYLENEX vials during routine stability testing. Baxter is working with the product's NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation.

The companies have notified the U.S. Food and Drug Administration, and Baxter will be contacting customers to request the return of product. 

HYLENEX recombinant is a tissue permeability modifier indicated as an adjuvant in subcutaneous fluid administration for achieving hydration; to increase the dispersion and absorption of other injected drugs; and in subcutaneous urography for improving resorption of radiopaque agents.

PRODUCT Spironolactone Tablets, USP 25 mg, 100-count bottle (NDC 0603-5763-21), 500-count bottle (NDC 0603-5763-28), Rx only. 
CODE
Lot T118F09A, exp 08/2011; Lot T118F09B, exp 08/2011
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville AL,  
REASON
Subpotent (Single Ingredient Drug): out of specification (OOS) stability results for assay 94.2% (specification 95.0-105.0%) at the 6-month time point.
VOLUME OF PRODUCT IN COMMERCE 20,413 bottles
DISTRIBUTION Nationwide

PRODUCT 
1) Motrin IB (Ibuprofen) Tablets USP 200mg, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottle , NDC 50580-109-02, UPC 300450463029; b) 50-count bottle , NDC50580-109-03, UPC 300450463036; c) 100-count bottle, NDC 50580-109-04, UPC 300450463043; d) 100+25-count bottle, NDC 50580-109-29, UPC 300450463296; e) 100+50-count bottle, NDC 50580-109-75, UPC 300450463753, OTC. 

2) Motrin IB (Ibuprofen) Tablets USP 200mg Coated Caplets, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottles, NDC 50580-110-03, UPC 300450481030; b) 24+6-count bottle, NDC 50580-110-64, UPC 300450481641; c)50-count bottle, NDC 50580-110-02, UPC 300450481023; d) 100- count bottle, NDC 50580-110-01, UPC 3004850481016; e) 100+25-count bottle, NDC 50580-110-95, UPC 300450481955; f) 100+50-count bottle, NDC 50580-110-75, UPC 300450481757; g) 225-count bottle, NDC 50580-110-62, UPC 300450481627; h) 300-count bottle, NDC 50580-110-37, UPC 300450481375, OTC. 

3) Motrin Junior Strength for ages 6-11 (Ibuprofen ) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Grape Flavored Chewable Tablets, 24-count bottle, NDC 50580-909-24, UPC 300450909244, OTC. 

4) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Easy-to-Swallow Caplets, 24-count bottle, NDC 50580-498-24, UPC 300450498243, OTC. 

5) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Orange Flavored Chewable Tablets, 24-count bottle, NDC 50580-207-24, UPC 300450494245, OTC. 
CODE
1) a) Lot # ABA003, Exp 11/30/2011; ADA258, Exp 2/28/2012; AFA309, Exp 3/31/2012; and AJA055, Exp 5/31/2012; b) Lot # ABA004, ABA152, Exp 11/30/2011; AFA228, Exp 3/31/2012; AHA024, Exp 4/30/2012; AJA007, Exp 5/31/2012; and AJA243 4/30/2012; c) Lot # AEA078, AEA261, Exp 3/31/2012 and AFA241, Exp 4/30/2012; d) Lot # AFA017 Exp 4/30/2012; and AJA168, Exp 1/31/2012; e) Lot # ALA109, Exp 7/31/2012;

2) a) Lot # AAA435, ABA369, Exp 11/30/2011; ADA174, Exp 2/28/2012; AHA026, and AJA006, Exp 4/30/2012; b) Lot # ADA246, Exp 2/28/2012; c) Lot # ABA153, Exp 10/31/2011; ABA541, Exp 12/31/2011; ADA173, Exp 2/28/2012; and AHA025, Exp 4/30/2012; d) Lots # ABA019, Exp 11/30/2011; ACA469, Exp 12/31/2011; ADA245, Exp 2/28/2012; AEA260, Exp 3/31/2012; AFA015, Exp 4/30/2012; AJA049, and AJA186, Exp 6/30/2012; e) Lot # ADA287, Exp 2/28/2012; and AFA016, Exp 4/30/2012; f) Lot # ABA538, Exp 0/31/2011; AJA023 and AJA120, Exp 6/30/2012; g) Lot # 24526, Exp 12/31/2009; 24544 ,24604, Exp 1/31/2010; 24591, Exp 3/31/2010; 24634, Exp 5/31/2010; 24687, 24762, Exp 7/31/2010; 24795, Exp 9/30/2010; 24794, 24818, Exp 11/30/2010; 24864, Exp 1/31/2011; 24905, 24915, Exp 2/28/2011; 24935, 24939, Exp 3/31/2011; 25013, Exp 4/30/2011; 24977, Exp 5/31/2011; 25044, 25980, Exp 6/30/2011; 25996, 26051, Exp 8/31/2011; 26085, Exp 10/21/2011; 26134, 26192, Exp 11/30/2011; 26241, 26335, Exp 1/31/2012; 26423, 26455, Exp 4/30/2012; 26508, Exp 6/30/2012; 26533, Exp 8/31/2012; h) Lot # ACA442, ACA759, ADA018, Exp Date 1/31/2012; ADA419, Exp Date 2/28/2012; AFA098, AFA112, AHA034, AHA068, ALA359, Exp Date 4/30/2012; ALA254, AMA177, AMA350, Exp Date 8/31/2012; APA217, Exp Date 9/30/2012; SEA208, Exp Date 3/31/2011; SFA184, SFA259, SHA107, Exp Date 4/30/2011; SJA131, SLA162, Exp Date 6/30/2011; SLA049, SMA013, SMA082, Exp Date 7/31/2011; and SSA157 Exp Date 9/30/2011;

3) Lot # ADM006, Exp Date 2/28/2011; ADM052, Exp Date 3/31/2011; AFM016, AFM350, Exp Date 5/31/2011; AHM420, Exp Date 6/30/2011; AJM346, ALM344, Exp Date 7/31/2011; ALM399, AMM379, Exp Date 9/30/2011; APM303, APM418, Exp Date 10/31/2011; APM429, Exp Date 11/30/2011; and SLM084, Exp Date 8/31/2010;

4) Lot # AJM322, Exp Date 7/31/2012; and APM348, Exp Date 10/31/2012;

5) a) Lot # ADM013, AFM024, Exp Date 3/31/2011; AHM402, Exp Date 6/30/2011; AJM345, ALM326, Exp Date 7/31/2011; ALM456, AMM381, Exp Date 9/30/2011; APM306, Exp Date 10/31/2011; and APM421, Exp Date 11/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, 
Manufacturer: Mcneil Healthcare, LLC, Las Piedras, PR. 
REASON
Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE
11,728,152 bottles
DISTRIBUTION Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

PRODUCT 
1) Acetasol HC (Hydrocortisone and Acetic Acid) Otic Solution, USP, Rx Only, 10 mL. NDC #0472-0882-82. 

2) Hydrocortisone and Acetic Acid Otic Solution USP, Rx only, 10 mL, NDC 45963-412-61.
CODE
1) Lot numbers: L904031, Exp 05/10; L905006, Exp 06/10; L906005, Exp 07/10; L908096, Exp 01/10 and L911011, Exp 12/10;

2) Lot numbers: L906074, Exp 07/10; L907008, Exp 08/10; L908096, Exp 10/10; and L911011, Exp 12/10
RECALLING FIRM/MANUFACTURER
Actavis Mid Atlantic LLC, Lincolnton, NC, 
REASON
Impurities/Degradation Products: Out-of-specification (OOS) stability results for hydrocortisone related compounds.
VOLUME OF PRODUCT IN COMMERCE
152,688 bottles
DISTRIBUTION Nationwide

PRODUCT DVM Hand Cleanser, Foaming Hand Cleanser, 0.375% triclosan, 18 -fl. oz bottles and 1-gallon jugs, OTC only, a) 18-fl. oz. bottles (NDC 59130-161-32), and b) 1-gal. jugs (NDC 59130-161-05). 
CODE
a) Lot numbers 072252427, Exp date Jul-12; 073233204, Exp date Dec-10; 073613466, Exp date Jan-11; 080233678, Exp date Feb-11; and 080724100, Exp date Apr-11; b) Lot numbers, 072252429, Exp date Jul-12; 073233205, exp date Dec-10; 073613467, Exp date Jan-11; 080233679, Exp date Feb-11; 080724101, Exp date Apr-11; 080724108, Exp date Apr-11; 082685749, Exp date Oct-11; 083116131, Exp date Nov-11; 083646455, Exp date Jan-12; 090330301, Exp date Feb-12; 090850680, Exp date Apr-12; and 091040800, Exp date May-12  
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc., Saint Joseph, MO, 
REASON
cGMP Deviation: The product was not manufactured in conformance with GMP'S.
VOLUME OF PRODUCT IN COMMERCE
44,862 bottles
DISTRIBUTION Nationwide

PRODUCT 
1) Pancuronium Bromide Injection 4 mg/2 mL (2 mg/mL) 2 mL Vials (NDC 0703-2812-01), packaged in 25 Vials per carton (NDC 0703-2812-04), Rx only. 

2) Pancuronium Bromide Injection 10 mg/5 mL (2 mg/mL) 5 mL Multiple Dose Vial (NDC 0703-2823-01), packaged in 25 Vials per carton (NDC 0703-2823-04), Rx only. 

3) Pancuronium Bromide Injection 10mg/10 mL (1 mg/mL) 10 mL Multiple Dose Vial (NDC 0703-2804-01), packaged in 10 Vials per carton (NDC 0703-2804-03), Rx only. CODE
1) Lot numbers: 07D127 Exp 4/2010 and 31303336B Exp 8/2011;
2) Lot numbers: 07E128 Exp 5/2010 and 07P132 Exp 11/2010;
3) Lot numbers: 07K118 Exp 8/2010 and 08A118 Exp 1/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. 
REASON
Impurities/Degradation Products: These products are being recalled because they do not meet specification for related substances.
VOLUME OF PRODUCT IN COMMERCE
561,075 vials
DISTRIBUTION Nationwide

WEEK ENDING MAY 8

PRODUCT
1) Erythromycin Ophthalmic Ointment USP, 0.5% (5 mg/g), Net Wt 1 gram, Sterile tube, Rx only; NDC 0168-0070-11. 

2) Bacitracin Zinc and Polymyxin B Salfate Ophthalmic Ointment USP, 500 bacitracin units + 10,000 polymyxin B units per gram, Net Wt 3.5 g (1/8 oz), Sterile, tube, Rx only; NDC 0168-0273-38. 

3) Gentamicin Sulfate Ophthalmic Ointment USP, 3 mg/gram, Net Wt 3.5 g (1/8 0z), Sterile, tube, Rx only; NDC 0168-0044-38.

4) Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP, 3.5mg Neomycin + 10,000 Polymyxin B units + 1mg Dexamethasone per gram; Net Wt 3.5 g (1/8 oz), Sterile, tube, Rx only; NDC 0168-0221-38. 

5) Puralube Ointment (Petrolatum Ophthalmic Ointment), Sterile Ocular Lubricant, Net Wt 1 gram, tube, OTC. NDC 0168-0150-11. CODE
1) Lots R46 (exp. 03/10), R50 (exp. 04/10), R64 (exp. 05/10), R66 (exp. 06/10), R77 (exp. 07/10), R78 (exp. 09/10), R79 (exp. 10/10), R80 (exp. 10/10), R82 (exp. 12/10), 50A (exp. 03/11), 52A (exp. 04/11), 53A (exp. 05/11), 56A (exp. 06/11);

2) Lot 67A (exp. 01/11);

3) Lot 13A (exp. 10/10;

4) Lot 29A (exp. 11/10);

5) Lots R09 (exp. 11/10), R56 (exp. 04/11), R90 (exp. 06/11), 68A (exp. 01/12)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc.,  Melville, NY, 
Manufacturer: Nycomed Us Inc., Hicksville, NY. g.
REASON Lack of Assurance of Sterility. Potential bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE 126,764 (for all 5 products)
DISTRIBUTION Nationwide

PRODUCT Claritin Eye (ketotifen fumarate) ophthalmic solution, Antihistamine Eye Drops, sterile, 0.025%, 5 mL (0.17 FL OZ), dropper bottle, OTC. NDC# 11523-7235-1. CODE
Lot Numbers: JH9861 (Exp Dec-11), JD2529V (Exp Jan-11), JD2532 (Exp Feb-11), JD2530 (Exp Feb-11), JD2531 (Exp Feb-11), JD2533 (Exp Feb-11), and JD3861 (Exp Feb-11). UPC code 0-41100-80586-7
RECALLING FIRM/MANUFACTURER
Apotex Corp.,Weston, FL
REASON Failed pH specifications.
VOLUME OF PRODUCT IN COMMERCE 906,926 bottles
DISTRIBUTION Nationwide

PRODUCT
1) Motrin IB (Ibuprofen) Tablets USP 200mg, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottle , NDC 50580-109-02, UPC 300450463029; b) 50-count bottle , NDC50580-109-03, UPC 300450463036; c) 100-count bottle, NDC 50580-109-04, UPC 300450463043; d) 100+25-count bottle, NDC 50580-109-29, UPC 300450463296; e) 100+50-count bottle, NDC 50580-109-75, UPC 300450463753, OTC.

2) Motrin IB (Ibuprofen) Tablets USP 200mg Coated Caplets, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottles, NDC 50580-110-03, UPC 300450481030; b) 24+6-count bottle, NDC 50580-110-64, UPC 300450481641; c)50-count bottle, NDC 50580-110-02, UPC 300450481023; d) 100- count bottle, NDC 50580-110-01, UPC 3004850481016; e) 100+25-count bottle, NDC 50580-110-95, UPC 300450481955; f) 100+50-count bottle, NDC 50580-110-75, UPC 300450481757; g) 225-count bottle, NDC 50580-110-62, UPC 300450481627; h) 300-count bottle, NDC 50580-110-37, UPC 300450481375, OTC. 

3) Motrin Junior Strength for ages 6-11 (Ibuprofen ) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Grape Flavored Chewable Tablets, 24-count bottle, NDC 50580-909-24, UPC 300450909244, OTC. 

4) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Easy-to-Swallow Caplets, 24-count bottle, NDC 50580-498-24, UPC 300450498243, OTC. 

5) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Orange Flavored Chewable Tablets, 24-count bottle, NDC 50580-207-24, UPC 300450494245, OTC. 
CODE
1) a) Lot # ABA003, Exp 11/30/2011; ADA258, Exp 2/28/2012; AFA309, Exp 3/31/2012; and AJA055, Exp 5/31/2012; b) Lot # ABA004, ABA152, Exp 11/30/2011; AFA228, Exp 3/31/2012; AHA024, Exp 4/30/2012; AJA007, Exp 5/31/2012; and AJA243 4/30/2012; c) Lot # AEA078, AEA261, Exp 3/31/2012 and AFA241, Exp 4/30/2012; d) Lot # AFA017 Exp 4/30/2012; and AJA168, Exp 1/31/2012; e) Lot # ALA109, Exp 7/31/2012;

2)  a) Lot # AAA435, ABA369, Exp 11/30/2011; ADA174, Exp 2/28/2012; AHA026, and AJA006, Exp 4/30/2012; b) Lot # ADA246, Exp 2/28/2012; c) Lot # ABA153, Exp 10/31/2011; ABA541, Exp 12/31/2011; ADA173, Exp 2/28/2012; and AHA025, Exp 4/30/2012; d) Lots # ABA019, Exp 11/30/2011; ACA469, Exp 12/31/2011; ADA245, Exp 2/28/2012; AEA260, Exp 3/31/2012; AFA015, Exp 4/30/2012; AJA049, and AJA186, Exp 6/30/2012; e) Lot # ADA287, Exp 2/28/2012; and AFA016, Exp 4/30/2012; f) Lot # ABA538, Exp 0/31/2011; AJA023 and AJA120, Exp 6/30/2012; g) Lot # 24526, Exp 12/31/2009; 24544 ,24604, Exp 1/31/2010; 24591, Exp 3/31/2010; 24634, Exp 5/31/2010; 24687, 24762, Exp 7/31/2010; 24795, Exp 9/30/2010; 24794, 24818, Exp 11/30/2010; 24864, Exp 1/31/2011; 24905, 24915, Exp 2/28/2011; 24935, 24939, Exp 3/31/2011; 25013, Exp 4/30/2011; 24977, Exp 5/31/2011; 25044, 25980, Exp 6/30/2011; 25996, 26051, Exp 8/31/2011; 26085, Exp 10/21/2011; 26134, 26192, Exp 11/30/2011; 26241, 26335, Exp 1/31/2012; 26423, 26455, Exp 4/30/2012; 26508, Exp 6/30/2012; 26533, Exp 8/31/2012; h) Lot # ACA442, ACA759, ADA018, Exp Date 1/31/2012; ADA419, Exp Date 2/28/2012; AFA098, AFA112, AHA034, AHA068, ALA359, Exp Date 4/30/2012; ALA254, AMA177, AMA350, Exp Date 8/31/2012; APA217, Exp Date 9/30/2012; SEA208, Exp Date 3/31/2011; SFA184, SFA259, SHA107, Exp Date 4/30/2011; SJA131, SLA162, Exp Date 6/30/2011; SLA049, SMA013, SMA082, Exp Date 7/31/2011; and SSA157 Exp Date 9/30/2011;

3) Lot # ADM006, Exp Date 2/28/2011; ADM052, Exp Date 3/31/2011; AFM016, AFM350, Exp Date 5/31/2011; AHM420, Exp Date 6/30/2011; AJM346, ALM344, Exp Date 7/31/2011; ALM399, AMM379, Exp Date 9/30/2011; APM303, APM418, Exp Date 10/31/2011; APM429, Exp Date 11/30/2011; and SLM084, Exp Date 8/31/2010;

4) Lot # AJM322, Exp Date 7/31/2012; and APM348, Exp Date 10/31/2012;

5) a) Lot # ADM013, AFM024, Exp Date 3/31/2011; AHM402, Exp Date 6/30/2011; AJM345, ALM326, Exp Date 7/31/2011; ALM456, AMM381, Exp Date 9/30/2011; APM306, Exp Date 10/31/2011; and APM421, Exp Date 11/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, 
Manufacturer:  McNeil Healthcare, LLC, Las Piedras, PR. 
REASON Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE 11,728,152 bottles
DISTRIBUTION Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

PRODUCT Diflorasone Diacetate Cream, USP, 0.05%, a) 15 grams per tube (NDC 0168-0242-15) and b) 30 grams per tube (NDC 0168-0242-30), Rx only. The product is packaged in a tube which is packed inside a unit cardboard carton. 
CODE
a) Lot# 976D, Exp 8/2011; b) Lot# 329D Exp 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, 
Manufacturer: Nycomed Us Inc., Hicksville, NY. g.  
REASON Superpotent (Single Ingredient) Drug: Out-of-specification (OOS) assay results both above and below the approved specification (90-110%) were found in the recalled lots.
VOLUME OF PRODUCT IN COMMERCE 22,779 tubes
DISTRIBUTION Nationwide

WEEK ENDING MAY 1

McNeil Consumer Healthcare Announces Recall of Certain OTC Infants’ and Children’s Products 

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc.,  is recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

McNeil Consumer Healthcare is  recalling some of these products which may not meet required quality standards. Parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.

Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com.

PRODUCTS

NDC Number

TYLENOL® INFANTS’ DROPS
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR

50580-144-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR*

50580-144-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE

50580-167-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR

50580-143-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR

50580-143-30
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE - HOSPITAL

50580-144-18
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE - SAMPLE

50580-144-40

CHILDREN’S TYLENOL® SUSPENSIONS
CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR

50580-123-02
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR

50580-123-04
CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR

50580-166-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH

50580-296-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR

50580-407-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR

50580-493-04
CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE

50580-123-01
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL

50580-123-03

CHILDREN’S TYLENOL® PLUS SUSPENSIONS
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR

50580-247-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR

50580-249-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR

50580-253-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR

50580-254-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR

50580-255-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR

50580-386-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR

50580-387-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR

50580-390-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR

50580-391-04

MOTRIN® INFANTS’ DROPS
CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE

50580-198-01
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE

50580-198-15
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR*

50580-100-15

CHILDREN’S MOTRIN® SUSPENSIONS
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE

50580-184-04
CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR

50580-601-02
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR

50580-601-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR

50580-215-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR

50580-603-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR

50580-604-04
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE

50580-603-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE

50580-604-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE

50580-601-01
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL

50580-601-50
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR

50580-902-04

CHILDREN’S ZYRTEC®  LIQUIDS IN BOTTLES
CHILDREN’S ZYRTEC®  4 OZ. BUBBLEGUM SYRUP

50580-721-04
CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP

50580-730-04
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE

50580-730-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM

50580-721-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID

50580-721-08

CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES
CHILDREN'S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID

50580-535-04


* CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR is also included in JOHNSON'S ® Baby Relief Kit.

*CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON'S ® Baby Relief Kit

PRODUCT Sterile Visine All Day Eye Itch Relief (Ketotifen Fumarate) Opthalmic Solution Antihistamine Eye Drops ; 0.17oz (5 ml) bottle; OTC; UPC Code: 31254749178. 
CODE
Lot numbers: JF7296, Exp. 5/2011; JF0102, Exp 4/2011; JD9060, Exp 3/2011; JD9059B, 3/2011; JD9059A, Exp. 3/3011, JD9059, Exp. 3/2011.
RECALLING FIRM/MANUFACTURER
Johnson & Johnson Consumer Group of Companies, Inc., Skillman, NJ, 
REASON Failed PH Specifications: out of specification (OOS) results for pH (results 4.229, limit is from 4.4 to 5.8) at the 6-month stability testing.
VOLUME OF PRODUCT IN COMMERCE 234,180 bottles
DISTRIBUTION Nationwide

PRODUCT MD Quality Hand Sanitizer, Gel, 0.13% Benzalkonium Chloride, 10 ounce Bottle. 
CODE Lot 02; Exp. date July 30, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Morales Distributors, Inc., Mayaguez, PR, 
Manufacturer: Puerto Rico Beverage Inc., Maunabo, PR. REASON Microbial contamination of Non-Sterile products. FDA samples showed contamination with Burkholderia cepacia (a.k.a. Pseudomonas cepacia).
VOLUME OF PRODUCT IN COMMERCE 41,550 bottles/10 oz each
DISTRIBUTION PR

PRODUCT Diovan HCT (valsartan and hydrochlorothiazide) tablets, USP, 320 mg/25 mg per tablet, 30 tablets count blister card, Rx only, NDC 0078-0472-15. CODE
Lots F0172 (exp. FEB 2011), F0179 (exp. FEB 2011), F0179A (exp. FEB 2011), and F0198 (exp. MAY 2011)
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals, Corp., Suffern, NY,
REASON Labeling: Incorrect Lot No(s): One of the two NDC numbers on the unit-dose blister-card is incorrectly printed as 0078-0471-15, which corresponds to Diovan HCT 320mg/12.5mg Tablets.
VOLUME OF PRODUCT IN COMMERCE 11,964 cartons of 6 shellpaks
DISTRIBUTION Nationwide

PRODUCT Spironolactone Tablets, USP 25 mg, 100-count bottle (NDC 0603-5763-21), 500-count bottle (NDC 0603-5763-28), Rx only. 
CODE
Lot T118F09A, exp 08/2011; Lot T118F09B, exp 08/2011
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, LLC, Huntsville, AL,
REASON Subpotent (Single Ingredient Drug): out of specification (OOS) stability results for assay 94.2% (specification 95.0-105.0%) at the 6-month time point.
VOLUME OF PRODUCT IN COMMERCE 20,413 bottles
DISTRIBUTION Nationwide

PRODUCT
1) Extra Strength Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) FRESGMINT Tablets, 675 mg/135mg, 100-count bottle, NDC 50580-746-01, UPC 312547650212, OTC. 

2) Original Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Peppermint Tablets, 550 mg / 110 mg, 150-count bottle, NDC 50580-772-15, UPC 312547651185, OTC. 

3) Extra Strength Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Fruit Tablets, 675 mg/135mg, 100-count bottle, NDC 50580-744-01, UPC 312547650243, OTC. 

4) Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Cherry Tablets, 550mg / 110mg, 150-count bottle, NDC 50580-773-15, UPC 312547652421, OTC. 

5) Rolaids MULTI-SYMPTOM Antiacid & Antigas (Calcium Carbonate, Magnesium Hydroxide & Simethicone) Berry Tablets, 675 mg/135 mg/80 mg, 100-count bottle, NDC 50580-748-01, UPC 312547654579, OTC. 

6) Extra Strength Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Tropical Punch Tablets, 675 mg/135mg, 100-count bottle, NDC 50580-745-01, UPC 312547654234, OTC. 
CODE
1) Lots # AAA011, AAA083, Exp date 9/30/2010; AAA399, Exp date 10/31/2010; ABA397, Exp date 11/30/2010; ACA439, Exp date 12/31/2010; ADA086, Exp date 1/31/2011; ADA180, ALA159, Exp date 2/28/2011; AEA197, AFA224, Exp date 3/31/2011; AEA250, AFA053, AFA293, AJA043, Exp date 4/30/2011; AJA114, Exp date 6/30/2011; ALA105, ALA273, Exp date 7/31/2011; AMA178, APA054, Exp date 8/31/2011; SJA113, SJA114, SJA115, SJA116, Exp date 5/31/2010; SJA259, SMA222, SSA351, Exp date 7/31/2010; SLA149, SMA032, Exp date 6/30/2010; SMA248, SPA024, SPA128, and SPA161, Exp date 8/31/2010;

2) Lot # AAA009, AAA202, Exp date 9/30/2010; AAA232, SLA370, SMA332, SPA129, SSA439, Exp Date 8/31/2010; ABA141, ABA268, Exp date 10/31/2010; ABA416 Exp date 11/30/2010; ABA554, ACA567, Exp Date 12/31/2010; ADA268, AEA072 Exp Date 2/28/2011; AFA009, Exp Date 4/30/2011; AFA171, Exp Date 5/31/2011; AJA178, Exp date 6/30/2011; AMA024, AMA267, AMA268, APA041, Exp Date 7/31/2011; SJA110, SJA111, SJA112, Exp Date 5/31/2010; SJA148, Exp date 5/30/2010; SLA084, SLA217, SLA367, Exp date 6/30/2010; SMA123, and SMA124, Exp Date 7/31/2010;

3) Lot # AAA086, Exp date 9/30/2010; ABA262, Exp date 10/31/2010; ACA256, Exp date 11/30/2010; ADA028, ADA082, Exp date 1/31/2011; AEA195, Exp date 3/31/2011; AFA234, Exp date 4/30/2011; AJA017, AJA018, AJA180, ALA026, Exp date 6/30/2011; AMA051, AMA208, SSA331, SSA332, Exp date 8/31/2011; APA152, Exp date 10/31/2011; SMA031, SMA099, SMA100, and SMA101, Exp date 7/31/2010;

4) Lot # ACA013, Exp date 12/31/2010; AEA057, Exp Date 2/28/2011; AFA317, Exp Date 5/31/2010; AJA016, Exp date 6/30/2010; AMA165, APA009, SPA036, SSA438, Exp date 9/30/2010; SLA087, Exp date 5/31/2010; and SSA334, Exp date 10/31/2010;

5) Lot # ABA009, ABA010, ABA011, ABA417, Exp Date 11/30/2010; ABA620, ACA438, Exp date 12/31/2010; ALA256, Exp Date 8/31/2011; APA042, Exp Date 9/30/2011; and ASA012, Exp Date 10/31/2011;

6) Lot # AAA359, SSA175, Exp Date 8/31/2010; SHA016, SHA017, SHA018, SJA204, Exp Date 5/31/2010; and SLA151, Exp 6/30/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, 
Manufacturer: Mcneil Healthcare, LLC, Las Piedras, PR. 
REASON Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE
8,842,812 bottles
DISTRIBUTION Nationwide, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, UAE

PRODUCT Gemfibrozil Tablets, USP, 600 mg, 60 count bottles (NDC: 57664-115-86), 500 count bottles (NDC: 57664-115-13); Rx only. 
CODE
Lot numbers: 90019B, Exp 1/11; 90032A, Exp. 2/11; 90032B, Exp. 2/11; 90032C, Exp 2/11; 90084A, Exp. 4/11. NDC: 57664-115-13 - 500 count Lot numbers: 90019A, Exp 1/11; 90031A, Exp. 2/11; 90033A, Exp. 2/11; 90033B, Exp. 2/11; 90033C, Exp. 2/11; 90043A, Exp. 2/11; 90044A, Exp. 2/11; 90045A, Exp. 2/11; 90046A, Exp. 2/11; 90047A, Exp. 2/11; 90076A, Exp. 6/11; 90077A, Exp. 6/11; 90085A, Exp. 4/11; 90092B, Exp. 5/11; 90092C, Exp. 5/11
RECALLING FIRM/MANUFACTURER
Sun Pharmaceutical Industries Inc., Cranbury, NJ,
REASON Impurities/Degradation Products: This product is being recalled because of Out of Specification results for the largest unspecified impurity at the 9-month stability test point.
VOLUME OF PRODUCT IN COMMERCE
12,036 bottles of 500 count; 14,670 bottles of 60 count
DISTRIBUTION Nationwide