JANUARY 2012

WEEK ENDING JANUARY 28

Cephalon, Inc. issues a recall of Treanda® (bendamustine HCL) for Injection 25mg/Vial Due to
Particulate Matter

Cephalon, Inc. is recalling Treanda® (bendamustine HCL) for Injection 25mg/8mL; lot TB30111, expiration date 12/2012.  This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.

Treanda® (bendamustine HCL) for Injection 25mg/8mL is indicated for the treatment of chronic lymphocytic leukemia (CLL).  

The affected Treanda® lot is packaged in 8 mL vials and was distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011. 

Recipients of the subject lot have been previously notified of this recall via overnight notification on 11/18/11 and are in the process of returning this product lot. Wholesalers, retailers, hospitals and health care professionals who have lot TB30111 in their possession are instructed to immediately cease using the product and immediately quarantine product for return. 

Consumers with questions regarding this recall may contact Genco at 877-319-8965 from 9:00am – 5:00pm CST Monday –Friday. 

PRODUCT Fluoxetine Capsules USP 10 mg, Rx only, 1000 Capsules, NDC 0781-2823-10. 
CODE Lot BR7539
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, 
Manufacturer:  Sandoz, Inc., Broomfield, CO. 
REASON Microbial contamination of non-sterile product (gelatin capsules contamination).
VOLUME OF PRODUCT IN COMMERCE 252 x 1000 ct bottles
DISTRIBUTION Nationwide

 

PRODUCT 0.9% Sodium Chloride Injection, USP, 500mL, NDC 0409-7983-03.
CODE Lot # 06-830-FW
RECALLING FIRM/MANUFACTURE
Recalling Firm: Hospira, Inc., Lake Forest, IL, 
Manufacturer: Hospira, Inc., Rocky Mount. NC. 
REASON Failed PH Specifications: The product is being recalled because of a confirmed out of specification result for pH.
VOLUME OF PRODUCT IN COMMERCE  479,352 bags
DISTRIBUTION Nationwide, U.S. Virgin Islands, Puerto Rico and Trinidad and Tobago

 

PRODUCT Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/mL, a) 1mL Vials (NDC 0703-6801-01); b) box of 25 single dose vials (NDC 0703-6801-04) and c) 1mL Prefilled Syringes (NDC 0703-6811-21), Rx only, For IM Use Only. 
CODE
a) Lot numbers 31310301B, exp 12/2011; 31310788B, exp 1/2012; 31311008B, exp 4/2012;  b) lot numbers - 31310787B, exp 1/2012; 31311357B, exp 4/2012; and c) lot numbers 31311217B, exp 2/2012; 31311219B, exp 2/2012; 31312156B, exp 4/2012; 31312300B, 4/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, .
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. 
REASON Presence of Particulate Matter; presence of silicone particles.
VOLUME OF PRODUCT IN COMMERCE 229,470 units
DISTRIBUTION Nationwide and PR

 

PRODUCT Fluocinonide, Ointment USP, 0.05%, NDC 51672-1264-2. Packaged in phenolic lacquer aluminum tubes with two sizes: 30g UPC: 351672126421; 60g UPC: 351672126438. 
CODE
Lot # J9066, 10/12; J9069, 10/12; J9070, 10/12; J9071, 10/12; K9001, 11/12; K9002, 11/12; K9003, 11/12; K9004, 11/12; K9005, 11/12; K9006, 11/12; K9007, 11/12; K9113, 11/12; K9114, 11/12; K9115, 11/12; K9116, 11/12; K9117, 11/12; K9118, 11/12; K9119, 11/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals USA, Inc., Hawthorne, NY, .
Manufacturer: Taro Pharmaceuticals, Inc., Brampton, Canada. 
REASON Impurities/Degradation Products: Out-of specification result for a known degradant Fluocinolone Acetonide. Taro Pharmaceuticals, Inc is recalling specific lots of Fluocinonide Ointment USP, 0.05% based on an investigation regarding out-of-specification (OOS) results for a known degradant observed in Fluocinonide Ointment USP, 0.05%, long-term stability lots # J9066 at 22-month interval, and # K9003 and # K9115 at 21-month intervals.
VOLUME OF PRODUCT IN COMMERCE 111,360 units
DISTRIBUTION Nationwide and Puerto Rico

WEEK ENDING JANUARY 21

 
PRODUCT Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/mL, 1mL Vials (NDC 0703-6801-01), pkg of 25 single vials (NDC 0703-6801-04) and 1mL Prefilled Syringes (NDC 0703-6811-21)
CODE 1mL single vials (NDC 0703-6801-01) - lot numbers 31310301B, exp 12/2011; 31310788B, exp 1/2012; 31311008B, exp 4/2012; pkg of 25 single vials (NDC 0703-6801-04) lot numbers - 31310787B, exp 1/2012; 31311357B, exp 4/2012 and 1mL prefilled syringe (NDC 0703-6811-21) - lot numbers 31311217B, exp 2/2012; 31311219B, exp 2/2012; 31312156B, exp 4/2012; 31312300B, 4/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA 18960
Manufacturing Firm: Teva Parenteral Medicines Inc, Irvine, CA 92618
REASON FOR RECALL Presence of Particulate Matter; presence of silicone particles

 

PRODUCT
1) Cyclafem(TM) 7/7/7, (norethindrone and ethinyl estradiol Tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7525-49) and 6 cards (NDC 0603-7525-17, Rx only. 
 
2) Cyclafem(TM) 1/35, (norethindrone and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7521-49) and 6 cards (NDC 0603-7521-17, Rx only. 
 
3) Emoquette(TM), (desogestrel and ethinyl estradiol tablets USP, 0.15 mg and 0.03 mg USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7521-49) and 6 cards (NDC 0603-7540-17), Rx only. ;
 
4) Gildess(R) FE 1.5/30, (norethindrone acetate and ethinyl estradiol Tablets USP and ferrous fumarate tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7608-17), Rx only. 
 
5) Gildess(R) FE 1/20, (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate, USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7609-17), Rx only. 
 
6) Orsythia(TM), (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7634-49) and 6 cards (NDC 0603-7634-17), Rx only.
 
7) Previfem(R), (norgestimate and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7642-17), RX only.
 
8) Tri-Previfem(R), (norgestimate and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7663-17), RX only. 
CODE
1) All lots within expiry, distributed from 01/20/2010 - 09/30/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7525-17 DDC XBM CFCX CBGW FFZH FFZH 0603-7525-49 CPTH CBGX FFZK;
2) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7521-17 DDH CPDK DKGY DMZV DMZY DMZX 0603-7521-49 CPFM ZSH CPFN CBGV DMZS;
3) All codes within expiry, distributed 01/20/2010 - 09/3/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7540-49 DGZZ DGZY CPGC 0603-7540-17 CPBS;
4) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # MNB MNM MNP ZNP ZNN CNMS DNBG FDGT DNBF;
5) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # MNG MNH MNK MWB MVZ MVY ZMY ZMZ CNMT DBSP DMDY DBSS DMPX FDYT DMPY FDGS DMPX FDYP DMPY DNBT FDYS DMPY DNBV;
6) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7634-49 FBNY 0603-7634-17 FBNX FBNW;
7) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # DCG DCF DCD CNYG CNYH DBMG DBMF DGGX DGGK DGGH DGGY DMPS DMPT FDGN DMPS;
8) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # CSZX DBT CSZW DBT CDYK CNYT DGHH DYZZ DGHK DYZY DGHK DZBB DGHK DVBD DGHH DGHM DGHN FFNX DNBY DBV DNBZ;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals LLC, DBA, Qualitest Pharmaceuticals, Huntsville, AL, 
Manufacturer: Patheon, Inc., Toronto Region Operations, Mississauga Ontario, Canada. 
REASON Contraceptive Tablets Out of Sequence; blister cards were rotated 180 degrees, reversing
the weekly tablet orientation.
VOLUME OF PRODUCT IN COMMERCE 3,220,845 cards
DISTRIBUTION Nationwide and Puerto Rico

 

PRODUCT Fluoxetine Capsules USP, 20 mg, 100-count capsules per bottle, Rx only, NDC 0781-2822-01. 
CODE Lot BU9661, Exp 06/14
RECALLING FIRM/MANUFACTURER Sandoz Inc., Broomfield, CO, 
REASON CGMP Deviations: The batch was not manufactured utilizing Good Manufacturing Processes.
VOLUME OF PRODUCT IN COMMERCE 37,971 bottles
DISTRIBUTION Nationwide

 

PRODUCT
1) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 100-count caplets per bottle, NDC 0067-2000-91, UPC 3 0067-2000-91 0. 
 
2) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 250-count caplets per bottle, NDC 0067-2039-07, UPC 3 0067-2039-07 1. 
CODE
1) Lot 10068948, Exp 03/12;
2) Lot 10084053, Exp 12/12
RECALLING FIRM/MANUFACTURER Novartis Consumer Health, Lincoln, NE, 
REASON Adulterated Presence of Foreign Tablets: Foreign tablets contained in bottles.
VOLUME OF PRODUCT IN COMMERCE 120,360 bottles
DISTRIBUTION Nationwide

 

PRODUCT Ramipril Capsules 1.25 mg, 100-count bottles, Rx only, Code No. GO/DRUGS/654. 
CODE Batch 3904946, Exp 10/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, 
Manufacturer: Lupin Limited, Goa, India. 
REASON Subpotent; 24 month stability timepoint.
VOLUME OF PRODUCT IN COMMERCE 4,560 bottles
DISTRIBUTION Nationwide

 

PRODUCT
1) Proactiv, Rodan & Fields, proactiv SOLUTION, Renewing Cleanser, benzyl peroxide acne treatment 8 Fl. oz 240 mL. 
 
2) Rodan & Fields proactiv SOLUTION, Repairing Treatment, benzyl peroxide acne treatment 3 Fl. oz 89 mL. 
 
3) Rodan & Fields proactiv SOLUTION CONCEALER PLUS non-comedogenic sulfur acne treatment .25 Fl. oz. 7.5 mL, Active ingredient Sulfur 8%. 
CODE
1) and 2) All Lots Proactiv Renewing Cleanser manufactured from April 15, 2009 forward that are labeled with 2 year expiration dating;
 
2) All Lots Proactiv Repairing Treatment manufactured from April 15, 2009 forward that are labeled with 2 year expiration dating;
 
3) Units: T8305A0F T8309A0J T8315A T8315A1A T8315A1K T9044A T9062A T9107A T9110A T9175A T9196A T9197A T9218A T9254A T9257A T0048A T0049A T0078A T0119A T0198A T0342A T0343A T1089A T1129A T1130A T1200A T1230A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guthy-Renker Corp., Santa Monica, CA,   
Manufacturer: Thibiant International, Inc., Chatsworth. CA. 
REASON
1) and 2) Stability Data does not Support Expiration Date;
3) Superpotent; sulfur
VOLUME OF PRODUCT IN COMMERCE 2,546,689 units
DISTRIBUTION Nationwide and Canada

 

PRODUCT
1) Nifedipine Extended Release Tablets, 60 mg, 100 Tablets, NDC: 63739-452-10, Rx only.
 
2) Nifedipine Extended Release Tablets, 30 mg, 100 tablets, Rx only, NDC 63739-451-10.
CODE
1) Lot number: 00074901;
2) Lot number: 00074888
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mckesson Packaging Services, Concord, NC, 
Manufacturer: Aptalis Pharma Inc., Vandalia, OH. 
REASON Failed USP Dissolution Test Requirements (below specification).
VOLUME OF PRODUCT IN COMMERCE 1,531 unit dose boxes (1,531,000 tablets)
DISTRIBUTION Nationwide

WEEK ENDING JANUARY 14

Rexall Issues Recall onUndeclared Shellfish in Calcium 1200mg plus Vitamin D 1000 IU Softgels

Rexall, Inc., of Deerfield Beach, Florida, announced a recall of Rexall Calcium 1200 mg plus 1000IU Vitamin D3, 60 softgels. The affected bottles actually contain a TABLET product, Triple Strength Glucosamine Chondroitin and MSM Tablets.

Because the product may contain trace quantities of undeclared shellfish, people who have an allergy or severe sensitivity to shellfish (e.g., shrimp, crab, lobster, clams or oysters) run the risk of serious or life-threatening allergic reaction if they consume this product.

Rexall Calcium 1200 mg plus 1000IU Vitamin D3 was distributed solely at Dollar General, which has 9,800 stores across 38 states. This recall involves only one lot number, 387651-04.

Product # Description UPC Code Label Expiration Date Lot Number
45211 Rexall Calcium 1200 mg plus 1000IU Vitamin D3, 60 softgels 3 01220 45211 3 Rexall 08/15 387651-04

Consumers who have this product in their possession can return it to Dollar General for a full refund or contact Rexall at 1-888-534-6370.

 
PRODUCT Fluoxetine Capsules USP, 20 mg, 100-count capsules per bottle, Rx only, Sandoz Inc., Princeton, NJ 08540, NDC 0781-2822-01.
CODE Lot BU9661, Exp 06/14
RECALLING FIRM/MANUFACTURER Recalling/Manufacturing Firm: Sandoz Incorporated, Broomfield, CO
REASON FOR RECALL CGMP Deviations: The batch was not manufactured utilizing Good Manufacturing Processes.

 

PRODUCT
1.      Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 100-count caplets per bottle, Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-2000-91, UPC 3 0067-2000-91 0.
2.      Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 250-count caplets per bottle, Dist. by Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-2039-07, UPC 3 0067-2039-07 1.
CODE
1.      Lot 10068948, Exp 03/12.
2.      Lot 10084053, Exp 12/12.
RECALLING FIRM/MANUFACTURER Recalling/Manufacturing Firm: Novartis Consumer Health, Lincoln, NE
REASON FOR RECALL Adulterated Presence of Foreign Tablets: Foreign tablets contained in bottles.

 

PRODUCT
1.      Excedrin Tension Headache Caplets packaged in 250-ct. btls (NDC 0067204507), 125-ct. btls (NDC 0067204584) and 100-ct. btls (NDC 0067204591), each caplet contains 500 mg. acetaminophen and 65 mg. caffeine. Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ
2.      Excedrin Extra Strength Tablets, packaged in 100-ct. btls (NDC 0067203091), 250-ct. btls (NDC 0067203077), and 300-ct. btls (NDC 0067203033), AND Excedrin Extra Strength Caplets, packaged in 24-ct. btls (NDC 0067200024), each tablet or caplet contains 250 mg. acetaminophen, 250 mg. aspirin, and 65 mg. caffeine. Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ.
3.      Excedrin, Extra Strength, Acetominophen, Aspirin (NSAID), and Caffeine, Pain Reliever/Pain Reliever Aid, Express Gels, 80 Gelcaps, NDC 0067627094, Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ.
4.      Excedrin Migraine Caplets, packaged in 24-ct. btls (NDC 0067203924) and 250-ct. btls (NDC 0067203777), each caplet contains 250-mg. acetaminophen, 250-mg. aspirin, and 65-mg. caffeine. Dist. by Novartis Consumer Health, Inc., Parsippany, NJ.
CODE
1.      250-ct - Lot #10063947, Exp. 11/30/2011; 125-ct - Lot #10089902, Exp. 4/30/2013; 100-ct - Lot #10087530, Exp. 3/31/2013.
2.      24-ct caplets - Lot #10085080, Exp. 1/31/2013; 100-ct tablets - Lot #10091817, Exp. 5/31/2013; 250-ct tablets - Lot #10092843, Exp. 6/30/2013; and 300-ct tablets - Lot #10073080, Exp. 6/30/2012
3.      Lot #10089353, Exp. 04/30/12.
4.      24 ct. - Lot #10074660, Exp. 7/31/2012; #10066070, Exp. 1/31/2012; #10066069, Exp. 1/31/2012; #10101757, Exp. 10/31/2013; and #10102541, Exp. 11/30/2013; and 250-ct. - Lot #10092845, Exp. 6/30/2013 and #10086758, Exp. 2/28/2013.
RECALLING FIRM/MANUFACTURER Recalling/Manufacturing Firm: Novartis Consumer Health, Lincoln, NE
REASON FOR RECALL Adulterated Presence of Foreign Tablets: Foreign tablets contained in bottles.

 

PRODUCT Acetylcysteine Solution, USP 20%, 200mg/mL, 30mL vials, Rx, NDC 0054-3026-02
CODE Lot 1877093, Item 0233-53-1877093, Exp 06/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ben Venue Laboratories, Inc., Bedford, OH
Manufacturer: Ben Venue Laboratories, Bedford, OH
REASON FOR RECALL Presence of Foreign Substance; glass particles identified during review of retain samples.

 

 PRODUCT
1) Plak-Vac Oral Care System, Memorial Hospital q2 Oral Care Kit, containing 4 - 0.5 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 6 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 12 - 2 gm. Tube Mouth Moisturizer, 2 - 1 oz. Medicine Cup, 12 - Foam Applicator Swabs, 10 - Suction Swabs, 4 - Non-Sterile 18 Fr. Suction Catheters, 1 - Yankauer Suction Instrument, 1 - Plak-Vac Storage Holder, 1 - Tubing Clamp, 1 - "Y" Connector, and 1 - Vent Bundle Checklist, Order No. 2381. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. 
 
2) Plak-Vac Oral Care System, St. John's Mercy Medical Center q2 Oral Care Kit, containing 6 - 0.34 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 6 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 12 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 12 - Foam Applicator Swabs, 22 - Suction Swabs, 1 - Yankauer Suction Instrument, 1 - Plak-Vac Storage Holder, and 1 - Plak-Vac Suction Toothbrush, Order No. 2330-A. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. 
 
3) Plak-Vac Oral Care System, Swedish Covenant Hospital, Non-Trach/Vent Oral Care Kit, containing 2 - 0.34 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 2 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 4 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 8 - Foam Applicator Swabs, 4 - Suction Swabs, 1 - Plak-Vac Suction Toothbrush, 1 - Plak-Vac Storage Holder, and 1 - Yankauer Suction Instrument, Order No. 2358. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. 
 
4) Plak-Vac Oral Care System, Swedish Covenant Hospital q4 Oral Care Kit, containing 4 Suction Swab, 12 Applicator Swab, 6 Mouth Moisturizer, 1 Yankauer Suction Instrument, 1 Plak-Vac Suction Toothbrush, 4 Mouthwash (H2O2), 2 Mouthwash (CPC), 1 Toothpaste, 2 Suction Catheter, and 1 Plak-Vac Storage Holder, Order No. 2329. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. 
 
5) Plak-Vac Oral Care System, Des Peres Hospital q4 Oral Care Kit, containing 4 - 0.5 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 2 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 6 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 6 - Foam Applicator Swabs, 4 - Suction Swabs, 2 - Non-Sterile 18 Fr. Suction Catheters, 1 - Yankauer Suction Instrument, and 1 - Plak-Vac Storage Holder, Order No. 2336. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. 
 
6) Plak-Vac Oral Care System, University of Tennessee Medical Center q4 Oral Care Kit, containing 3 - 0.34 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 3 - 0.5 oz. Pack Mint CPC Mouthwash (0.5% Cetylpyridinium Chloride), 6 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 6 - Foam Applicator Swabs, 4 - Suction Swabs, 2 - Non-Sterile 18 Fr. Suction Catheters, 1 - Yankauer Suction Instrument, 1 - Plak-Vac Storage Holder, 1 - Sani-Stor Yankauer Storage Holder, and 1 - Plak-Vac Suction Toothbrush, Order No. 2460. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. 
CODE
1) Kit Lot #: 101011; Mouthwash Lot # 13068;
2) Kit Lot #: 082611, 090611, 091211, 091411, 091611, 092611, and 092911; Mouthwash Lot # 13068;
3) Kit Lot #: 092711, 0390016-090711, and 0390077-090811; Mouthwash Lot # 13068;
4) Kit Lot #: 0390016-090711 and 0390963-101111; Mouthwash Lot # 13068;
5) Kit Lot #: 389839; Mouthwash Lot # 13068;
6) Kit Lot #: 092211; Mouthwash Lot # 13068
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trademark Medical LLC, Ballwin, MO,
Manufacturers: Care Line Inc., Greenbrier, TN;
Birchwood Laboratories, Inc., Eden Prairie, MN. 
REASON Microbial Contamination of Non-Sterile Products: The mouthwash component of the kit was found to be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE 2,200 kits
DISTRIBUTION IL, MO, KY, and TN

 

 PRODUCT Ovcon 50 (Norethindrone and ethinyl estradiol ) Tablets, 1 mg/50 mcg, USP, NDC #0430-0585-45, (Trade) NDC #04300585-95 (Sample). 
CODE Units: 02260F, 504705A, 504705B (Sample)
RECALLING FIRM/MANUFACTURER Warner Chilcott Company LLC, Fajardo, PR, 
REASON Subpotent (Multiple Ingredient Drug)
VOLUME OF PRODUCT IN COMMERCE 23,364 blisters
DISTRIBUTION Nationwide
 
PRODUCT
1) Maalox Advanced Maximum Strength Antacid & Anti-gas, each teaspoonful contains 400 mg aluminum hydroxide (equiv. to dried gel, USP), 400 mg magnesium hydroxide, and 40 mg simethicone, Cherry Flavored Liquid packaged in 12-fl. oz. bottles, NDC 0067-6280-12. 
 
2) Premium Liquid Maalox Nighttime, Antacid with Acid Reflux Barrier, Mint, each teaspoonful contains 300-mg calcium carbonate, 125-mg magnesium carbonate, and 275-mg sodium alginate, packaged in 350-mL bottles, --- NPN 02248635. 
 
3) Extra Strength Stomak-Care Multi Action, Bismuth Subsalicylate Suspension, Peppermint, contains 35 mg/mL bismuth subsalicylate, packaged in 350-ml. bottles, --- DIN 02262363. 
 
4) Buckley's Complete, each teaspoonful contains 325-mg acetaminophen and 20-mg menthol, packaged in 150- and 250-ml. bottles --- DIN 02279703. 
CODE
1) Lot 10105720, Exp. Feb 2013;
2) Lot 10113253, Exp. Apr 2013;
3) Lot 10106536, Exp. Mar 2013;
4) 150 ml - Lot 10112301, Exp. Apr 2013 and 10107573, Exp. Jan 2013; 250-ml - Lot 10106138, Exp. Apr 2013; 10105856, Exp. Jan 2013, and 10105855, Exp. Jan 2013
RECALLING FIRM/MANUFACTURER Novartis Consumer Health, Lincoln, NB, 
REASON Presence of Foreign Substance; a small amount of non-USP water leaked into the batches due to a seal breach on a pump.
VOLUME OF PRODUCT IN COMMERCE 40,620/350-mL bottles, 83,292/250-mL bottles, 91,656/150-mL bottles, and 200,508/12-fl. oz. bottles
DISTRIBUTION Nationwide, and Canada

 

PRODUCT
1) Ondansetron Hydrochloride Tablets, 4 mg, 1 Card x 3 Tablets per carton, Rx only, NDC 0093-0233-33. 
 
2) Ondansetron Hydrochloride Tablets, 8 mg, 1 Card x 3 Tablets per carton, Rx only, NDC 0093-7236-33. 
CODE
1) Lot # Y04033, Exp 12/12;
2) Lot # Y05037, Exp 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,  
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON Labeling: Incorrect or Missing Package Insert: Packages contain out-dated product inserts.
VOLUME OF PRODUCT IN COMMERCE 3,732 cartons
DISTRIBUTION Nationwide 

 

PRODUCT
1) Hemorrhoidal Pads (witch hazel 50%), 100-count Pads per jar, labeled Best Choice Health Care, UPC 0-70038-5925. 
 
2) Pre-Moistened Hemorrhoidal/Vaginal Pads (witch hazel 50%), 100-count Pads per jar, labeled BI-MART, UPC 0-71357-00724. 
 
3) Hygenic cleansing Medicated Pads (witch hazel 50%), 100-count pads per jar, labeled Publix, UPC 0-41415-25573-9. 
 
4) Hygienic Cleansing medicated pads, 100-count pads per jar, labeled Shopko, UPC 4-00031-80411-8. 
 
5) Cleansing Pads (witch hazel 50%),100-count Pads per jar, labeled TopCare, UPC 0-36800-06868-1. 
 
6) Medicated Pads (witch hazel 50%), 100-count Pre-Moistened Hemorrhoidal/Vaginal Pads per jar, labeled Western Family, UPC 0-15400-06166-7. 
CODE
1) Lot 030810017, Exp 12/13;
2) Lot 0308100017, Exp 12/13;
3) Lot 0308100005, Exp 03/13;
4) Lot 030810005, Exp 03/13; Lot 030810017, Exp 12/13;
5) Lot 030810003, Exp 03/13;
6) Lot 030810017, Exp 12/13
RECALLING FIRM/MANUFACTURER G & W Laboratories Inc., South Plainfield, NJ, 
REASON Stability Data Does Not Support Exp: Three lots failed to meet specifications for alcohol content through the expiration date.
VOLUME OF PRODUCT IN COMMERCE 28,248 jars
DISTRIBUTION Nationwide

 

PRODUCT Ciclopirox Gel, 0.77%, 45 gram tube, Rx Only, UPC 3 0574-2061-45 7, NDC # 0574-2061-45. 
CODE Lot #: 2010433330, Exp. 10/12; 2011155328, Exp. 04/13
RECALLING FIRM/MANUFACTURER Paddock Laboratories, Inc., Minneapolis, MN, 
REASON Impurities/Degradation Products: Two lots did not conform to product specifications for an unspecified impurity at the 9 month stability test station.
VOLUME OF PRODUCT IN COMMERCE 24,664 Tubes
DISTRIBUTION Nationwide and Puerto Rico

Bedford Laboratories Issues Recall Of Polymyxin B For Injection USP And Vecuronium Bromide For Injection Related To Glass Particles

Bedford Laboratories today issued updated guidance on the product recalls:
 


The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed above to the user level.

Should wholesalers/distributors/retailers still have product which is being recalled, they should stop use and contact Bedford Laboratories Client Services at 800.562.4797.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers, or patients with product quality compliance, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 800.521.5169. Any adverse reactions experienced with any of the lots reported in this release should be also reported to 800.521.5169.

Novartis Consumer Health Inc. Issues Recall of Certain Over-The-Counter Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

Novartis Consumer Health, Inc. (NCH) is recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

These over-the-counter products were distributed nationwide to wholesalers and retailers.

Novartis Consumer Health Inc. is notifying its distributors and customers and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.

Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund. For more detailed information, consumers should visit our website at www.novartisOTC.com as of January 9, 2012. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

WEEK ENDING JANUARY 7

 
PRODUCT Squeeze Pod, Alcohol-Free, Moisturizing Hand Sanitizer with 0.13% BKC (0.75 mL). 
CODE Lot #: A32122, Exp. 06/13-A
RECALLING FIRM/MANUFACTURER
Recalling Firm: K. W. Griffen Company, DBA Biomed Packaging Systems, Norwalk, CT, .
Manufacturer: Bentley Laboratories LLC, Edison, NJ. 
REASON Microbial contamination of Non-Sterile Products: Product contaminated with bacteria-Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE 194, 040 pods
DISTRIBUTION CT

 

PRODUCT Lantus (insulin glargine [rDNA origin] injection) 10 mL Vial, 100 units/mL, Rx only, in cartons of 1 vial each; NDC 0088-2220-33. 
CODE A1259, 1/31/2013 A1271, 2/28/2013 A1295, 3/31/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sanofi-aventis US, Inc., Bridgewater, NJ, 
Manufacturer: Gruppo Lepetit Srl, Anagni, Italy. 
REASON Lack of Assurance of Sterility.
VOLUME OF PRODUCT IN COMMERCE 226,880 cartoon boxes (1 vial/box)
DISTRIBUTION Nationwide

 

PRODUCT Super Soft Sanitizer (benzalkonium chloride), 0.13%, 0.5 fl. oz. (15 mL) HDPE bottles, distributed under the following labels: a) Allstate.; b) NTMA; and c) Got Room for More?.  
CODE Lot #: A32122
RECALLING FIRM/MANUFACTURER
Recalling Firm: Humphreyline Inc., Florence, KY, 
Manufacturer: Bentley Laboratories LLC, Edison, NJ. .
REASON Microbial Contamination of Non-Sterile Products: Samples of the recalled OTC product were laboratory tested and found to be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE 1,798 bottles
DISTRIBUTION Nationwide

 

PRODUCT Glenmark Clotrimazole Cream USP, 1%, 30g, Rx only, NDC 68462-181-35. 
CODE Batch #02111245, exp March 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glenmark Generics Inc., USA, Mahwah, NJ, .
Manufacturer: Glenmark Generics Limited, Colvale Bardez, India. 
REASON Label Mix Up; Products immediate container (tube) is labeled as Ciclopirox Cream but actually contains Clotrimazole Cream. The outer carton is correctly labeled as Clotrimazole Cream
VOLUME OF PRODUCT IN COMMERCE 16,116 tubes
DISTRIBUTION Nationwide
___________________________________
PRODUCT
1) Chlorpap PEH DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0104-01.
 
2) Chlorpap PSE, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0101-01.  
 
3) Chlorpap PSE DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0102-01 
 
4) Maxichlor DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0448-01.  
 
5) Maxichlor PEH, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0444-01. 
 
6) Maxichlor PEH DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0445-01.  
 
7) Maxichlor PSE, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0442-01. 
 
8) Maxichlor PSE DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0443-01. 
 
9) Chlorpap, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0100-01. 
CODE
1) Lot 09G009;
2) Lot 09G002;  
3) Lot 09G005;
4) Lot 09M009;
5) Lot 09M011;
6) Lot 09M010;
7) Lots 09F023, 09F024 09F025;
8) Lots 09F028, 09F029, 09F030;
9) Lot 09G001
RECALLING FIRM/MANUFACTURER TG United, Inc., Brooksville, FL, 
REASON CGMP Deviations: TG United, Inc. is recalling Chlorpap and Maxichlor tablet drug products for blending problems.
VOLUME OF PRODUCT IN COMMERCE 8,089 bottles and 659,660 professional samples
DISTRIBUTION Nationwide

 

PRODUCT
1) Amlodipine Besylate Tablets, 2.5 mg, 90 count bottle, NDC 60505-0193-03, and 1000 count bottle, NDC 60505-0193-02, Rx Only. 
 
2) Amlodipine Besylate Tablets, 5 mg, 90 count bottle, NDC 60505-0194-02, and 1000 count bottle, NDC 60505-0194-03. 
 
3) Amlodipine Besylate Tablets, 10 mg, 90 count bottle, NDC 60505-0195-02 and 1000 count bottle, NDC 60505-0195-03. 
CODE
1) JD0780 Exp 02/2011, JE3558 Exp 03/2011, JF5111 Exp 05/2011, JE3555 Exp 03/2011, JF5110 Exp 05/2011, JG6578 Exp 07/2011;
 
2) JD0787 Exp 02/2011, JD4612 Exp 02/2011, JD4613 Exp 02/2011, JF5172 Exp 06/2011, JD0872 Exp 02/2011, JD4611 Exp 02/2011, JF5171 Exp 06/2011, JG6592 Exp 07/2011;
 
3) JD0788 Exp 02/2011, JD4614 Exp 03/2011, JD4615 Exp 03/2011, JE7873 Exp 04/2011, JE7876 Exp 04/2011 JF1994 Exp 04/2011, JD0789 Exp 02/2011, JE7881 Exp 04/2011, JE7882 Exp 04/2011, JF5173 Exp 06/2011, JF5174 Exp 07/2011, JG6603 Exp 07/2011
RECALLING FIRM/MANUFACTURER Apotex Inc., Toronto Ontario, Canada, 
REASON Impurities/Degradation Products: tablets failed routine stability studies.
VOLUME OF PRODUCT IN COMMERCE 569,228 bottles
DISTRIBUTION Nationwide and to Haiti & Saudi Arabia