FEBRUARY 2006

WEEK ENDING FEBRUARY 4

PRODUCT Oxygen Compressed USP, size M6, D, E, C, M, and MN cylinders
CODE All lots
RECALLING FIRM/MANUFACTURER Tri State Incorporated, Wauseon, OH
REASON cGMP deviations: FDA inspection of the recalling firm found that the Auto HP computerized filling system is not validated and there is no way to verify the automated vent and vacuum purge step during the prefill cycle.
VOLUME OF PRODUCT IN COMMERCE 359 cylinders
DISTRIBUTION Nationwide

PRODUCT Tylenol Severe Sinus Congestion Caplets with Instant Coolburst Senstation, (Acetaminophen 325mg and Guaifenesin HCl 30mg), 48 caplets blister package, Daytime, Non-Drowsy, CODE Lot number LCM138, Exp. 1/07
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil - PPC, Inc., Fort Washington, PA,
REASON Product intended for destruction due to preheater temperature (for foil backing) below validated range was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT St. Joseph Enteric-coated Tablets, (Aspirin), 81mg, 180 count bottles
CODE Lot number JPM036, Exp. 9/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil - PPC, Inc., Fort Washington, PA
REASON cGMP Deviations; Product intended for destruction due to incorrect set up/filler slats and scales, resulting in short counts was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT Children’s Motrin Suspension, (Ibuprofen), in each 5mL 100mg, 1 fl oz (30mL) bottle, Grape Flavor, Pain Reliever/Fever Reducer
CODE Lot number LDM026, Exp. 3/08
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil - PPC, Inc., Fort Washington, PA
REASON Short Fill: Product intended for destruction was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT Paclitaxel Injection, 30mg/5ml (6mg/mL), 5mL Multiple-Dose Vial, Must be Diluted Prior to IV Use, Rx only, NDC 55390-114-05
CODE Lot number 779946, expiration date 03/07
RECALLING FIRM/MANUFACTURER Bedford Laboratories, Bedford, OH
REASON Labeling Illegible: Unit carton may contain double embossing of the correct lot number and expiration date and an incorrect lot number and expiration date.
VOLUME OF PRODUCT IN COMMERCE Approximately 1,592 vials
DISTRIBUTION Nationwide and PR

PRODUCT Sterile Multiple-Dose Vial * Allergenic Extract * Box Elder * Acer Negundo * 1:10 W/V * Rx Only * Product is packed in Type 1 glass vials, stoppered with latex stoppers, and sealed with aluminum crimp caps
CODE Item number 82A01, Lot number 34795, 1:10 W/V, 50 mL; Item number 82A03, Lot number 36613, 1:10 W/V, 10 mL and Item number 82A06, Lot number 36730, 20, 000 PNU/ mL 30 mL
RECALLING FIRM/MANUFACTURER Greer Laboratories, Inc., Lenior, NC
REASON Mislabeling: Products were labeled with an incorrect PNU value.
VOLUME OF PRODUCT IN COMMERCE 19 units
DISTRIBUTION Nationwide

PRODUCT Clindamycin Hydrochloride Capsules USP, 150mg, Rx only, NDC 0591-5708-01
CODE P05F0323, P05G0332, P05G0333, and P05G0334
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories, Inc., Corona, CA
Manufacturer: Watson Laboratories, Inc., Humacao, PR. 
REASON Contamination: Four lots are being recalled due to a slight possibility of contamination with Trazadone.
VOLUME OF PRODUCT IN COMMERCE 38,825 bottles
DISTRIBUTION Nationwide and PR

WEEK ENDING FEBRUARY 11

PRODUCT Mylanta Gelcaps (Calcium Carbonate 550mg) 50 solid gelcaps, OTC, NDC 16837-850-50
CODE Lot number JDM166 exp 3/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Microbial Contamination: product intended for destruction due to pseudonomas aeruginosa found in water port was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Children’s Tylenol Strawberry Suspension 4 oz. Acetaminophen (APAP) 160 mg per 5 ml suspension, OTC, NDC 50580-493-04
CODE Lot number JFM184 exp 6/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Presence of particulate matter: product was intended for destruction due to a piece of latex glove found on a mesh screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Simply Sleep (Diphenhydramine HCI-25 mg) Nighttime Sleep Aid, 130 mini-caplets, OTC, NDC 50580-843-13
CODE Lot number JJM120 exp 7/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA.
REASON Presence of foreign tablets: product intended for destruction due to foreign tablets found in filler was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Simply Sleep (Diphenhydramine HCI-25 mg) Nighttime Sleep Aid, 100 mini-caplets, OTC, NDC 50580-843-10
CODE Lot number JJM121 exp 7/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Presence of foreign tablets: product intended for destruction due to foreign tablets found in filler was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Histex I/E Capsules (Carbinoxamine Maleate) 2mg/8mg, 60 count bottles and bulk containers, Each capsule contains: Carbinoxamine Maleate 2mg designed for immediate-release to provide rapid action, Carbinoxamine Maleate 8mg in a specially prepared base to provide extended-release action, Rx Only, NDC 67336-050-60 and NDC 67336-050-99
CODE 60 count bottles; Lot Numbers: 3327 Exp. Date 04/05, 3328 Exp. Date 04/05, 3329 Exp. Date 04/05, 3430 Exp. Date 05/05, 4348 Exp. Date 04/06; 4441 Exp. Date 05/06; 4459 Exp. Date 05/06; 4664 Exp. Date 08/06; 5066 Exp. Date 12/06; 5211 Exp. Date 02/07; 5494 Exp. Date 05/07; 5693 Exp. 08/07; 5694 Exp. Date 06/07; and 5901 Exp. Date 10/07 AND Bulk capsules: Lot Numbers: 3327 Exp. Date 04/05, 3430 Exp. Date 05/05, 3581 Exp. Date 07/05, 4348 Exp. Date 04/06; 4664 Exp. Date 08/06; 5066 Exp. Date 12/06; 5337 Exp. Date 02/07; 5494 Exp. Date 05/07; and 5747 Exp. Date 09/07
RECALLING FIRM/MANUFACTURER PharmaFab Lp, Grand Prairie, TX
REASON Product does not meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 11,860,294 total capsules
DISTRIBUTION TN and MI

PRODUCT Children’s Motrin Chewable Grape Flavor (Ibuprofen tablets 50mg) 24 chewable tablets, OTC, NDC 50580-907-24
CODE Lot number JPM035 exp 10/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON cGMP Deviations: product intended for destruction due to an incorrect batch formulation of the active ingredient was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Anagrelide HCI Capsules, 0.5 mg, 100 count bottle, Rx Only, NDC 0115-4611-01
CODE Lot number 4100831
RECALLING FIRM/MANUFACTURER Impax Laboratories, Inc., Hayward, CA
REASON Exceeded Impurity Specification.
VOLUME OF PRODUCT IN COMMERCE 0.5: 2086 bottles
DISTRIBUTION Nationwide

WEEK ENDING FEBRUARY 18

Cytosol Laboratories, Inc. Product Contains Dangerous Levels of Endotoxin

Cytosol Laboratories, Inc., of Braintree, Mass., recalls of all brands and sizes of Balanced Salt Solution (BSS) that the firm manufactures.  BSS is a drug used by health professionals to irrigate a patient's eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery.

Product lots were found to have elevated levels of endotoxin.  Endotoxins, also known as pyrogens, are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions.  

The Company is taking immediate action to retrieve all inventories of the product, including any existing stock at physician offices and hospitals. 

An estimated one million units of BSS products were distributed between December 2003 and December 2005. The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:

"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.

Individuals with questions may call FDA at 1-888-463-6332. Any adverse reactions or problems experienced with the use of this product should also be reported to the FDA MedWatch Program by completing a form online on the MedWatch web site at www.fda.gov/medwatch/report.htm, by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

AMO Recall release:  http://www.eyeworld.org/ewweek.php?id=394&query=amo%20recall#2

PRODUCT
a) Vicodin ES, Hydrocodone bitartrate and acetaminophen tablets, USP, 7.5mg/750 mg.
500 count bottles. CIII
b) Vicodin Tablets, (hydrocodone bitartrate and acetaminophen, USP 5mg/500mg), in 500 count,
white plastic bottles. CIII, 
CODE
a) Lot Number: 05VICE5019, Exp. 6/2008; 05VICE5020, Exp. 6/2008;
05VICE5021, Exp. 6/2008; 05VICE5022 Exp. 6/2008;
b) Lot Code: 05VICR5011, 7/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, North Chicago, IL
Manufacturer: Abbott Laboratories, Whippany, NJ. 
REASON Defective Container: tamper-evident foil seal is partially adhered on some bottles.
VOLUME OF PRODUCT IN COMMERCE 11,576 bottles
DISTRIBUTION Nationwide

WEEK ENDING FEBRUARY 25

PRODUCT AMO Endosol, Balanced Salt Solution, Each mL contains: Sodium chloride 0.64%; potassium chloride 0.075%; calcium chloride, dihydrate 0.048%, magnesium chloride, hexahydrate 0.03%; sodium acetate, trihydrate 0.39%; sodium citrate, dihydrate 0.17%, 500mL Glass Bottles and 18mL and 500mL plastice bottles, Rx only, 
CODE 500 mL Glass Bottles NDC 23731-8100-5, Lot #s A5l5B A51B A52B A537B A53B C519D D556B F521B F523B F525B F526B F527B G516B G517B G532B G536B G545B H516B H517B H518D H519B H520B H545B H554B K527B M41B M42B M43B M44B M48B ---- 18mL Plastic Bottles NDC 23731-8100-8, Lot #s B526J B527J B535J B536J B552J C529E C530E C537E C538E C539E C544E C545E C546E C547E C56E C57E C58E D510E D51lE D512E D513E D51E D570L D59E E528K E528L E529K E529L E531K E531L E532K E532L F520K F520L F530K F530L F56K F56L H524K H54K H552K J53K ----- 500mL Plastic Bottles, NDC 23731-8100-1, Lot #s A514B A525B A526B B515D B516D B547D C510D C51lD C512D C513B D521B E515B E516B E539B E540B F414B F415B F514B F533B F534B F54B F55B G413B G414B G415B G416B G417B G519B G520B G527B G528D G544B G547B H527B H528D H546B H558D J524B J525B J526B M416B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA
Manufacturer: Cytosol Laboratories, Inc., Braintree, MA. 
REASON Failed Pyrogen Test Specifications
VOLUME OF PRODUCT IN COMMERCE 370,338 bottles
DISTRIBUTION Nationwide, Dominican Republic, and Barbados

PRODUCT
a) Furosemide Tablets, USP, 40mg, 1000 and 5000 count bottles (packaged in white HDPEbottles), Rx only, NDC 0603-3740-32 (1000s) and NDC 0603-3740-34 (5000s)
b) Furosemide Tablets, USP, 80mg, 500 and 1000 count bottles (packaged in white HDPE bottles),
Rx only, NDC 0603-3751-28 (500s) and NDC 0603-3741-32 (1000s)
CODE
a) Lot Nos.: T012J04A, exp 09/06; T013J04A, exp 09/06; T013J04B, exp 09/06;
b) Lot Nos.: T009J04A, exp 09/06; T009J04B, exp 09/06
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL
REASON Mold Growth
VOLUME OF PRODUCT IN COMMERCE 5,772 units
DISTRIBUTION Nationwide

PRODUCT Metformin Hydrochloride Extended-Release Tablets 500 mg, 100 count bottles, Rx only, NDC 0172-4435-60
CODE 142691A
RECALLING FIRM/MANUFACTURER Ivax Pharmaceuticals, Inc., Cidra, PR
REASON Subpotent
VOLUME OF PRODUCT IN COMMERCE 8,459 bottles (100-count)
DISTRIBUTION Nationwide

PRODUCT Nifediac CC (Nifedipine) Extended-Release Tablets, USP 30 mg,100 count bottles, Rx only, NDC 0093-5272-01
CODE Lot number’s: 000407T12 exp 05/2006, 000410T15 exp 08/2006, 000412T53 exp 01/2006, 000503T03 01/2007 and 000505T25 exp 02/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals, USA Sellersville, PA,
Manufacturer: Biovail Corporation, Mississauga, Ontario, Canada
REASON Superpotent
VOLUME OF PRODUCT IN COMMERCE 45,347 bottles
DISTRIBUTION Nationwide

Hanford Pharmaceuticals Issues a Nationwide Recall of Cefazolin for Injection Because of Possible Health Risk

Hanford Pharmaceuticals Inc., of Syracuse, NY, is recalling four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials, an antibiotic used in a hospital environment.  Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus) which may pose a serious or life-threatening risk for some patients.  Cefazolin for Injection, USP is used to treat skin and skin structure, respiratory and other infections.

The firm is notifying its customers and users of the recall by letter, and asking that they stop distribution, recall from their accounts, and request the return of the recalled lots. Hospitals, clinics, and users should stop using the affected lots immediately. The letter advises that the product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Check the lot numbers on the product label and promptly return any with the following lot numbersSandoz product - C4650, C4537; Watson product - C4689, C4665.

Patients who feel that they may have experienced an adverse reaction to recalled product should seek medical help. 

Patients or users can contact the firm at (315)  476-7418.