JUNE 2005

WEEK ENDING JUNE 4

PRODUCT Famotidine Injection, 20mg/2mL, 10x2mL Single dose vials, Each mL contains 10mg of famotidine, for the Preparation of IV Solutions, Rx Only. NDC 55390-029-10. 
CODE Lot #609336, exp. 04/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bedford Laboratories, Bedford, OH
Manufacturer: Ben Venue Laboratories Inc, Bedford, OH. 
REASON Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE 146,660 vials.
DISTRIBUTION Nationwide.

PRODUCT Paxil (Paroxetine HCl) Tablets, 10mg, scored Tablets, Rx only, NDC 0029-3210-1330. 
CODE Lots: 64-4B10 & F64-4B10.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smithkline Beecham Pharmaceuticals Co. Cidra, PR
Manufacturer: Sb Pharmco Puerto Rico Inc., Cidra, PR. 
REASON Superpotent: These lots are being recalled because they contain a low incidence of tablets with elevated weights and assay.
VOLUME OF PRODUCT IN COMMERCE 78,097 units.
DISTRIBUTION Nationwide.

PRODUCT Oxycodone and Acetaminophen Capsules, USP* 5 mg/500mg * Each capsule contains: Oxycodone Hydrochloride USP and Acetaminophen, USP * 100 Capsules * Rx only. NDC 0603-4997-21. 
CODE C1180603A.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals Inc, Charlotte, NC
REASON Dissolution Failure (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 2,752 bottles.
DISTRIBUTION AL.

PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 30 mg., Rx only, packaged in 100 tablet bottle containers. Product label contains NDC 0456-0458-01 (FOREST). 
b) Armour Thyroid (thyroid tablets, USP), 60 mg., Rx only, packaged in 100 tablet bottle containers. Product label contains NDC 0456-0459-01 (FOREST). 
c) Armour Thyroid (thyroid tablets, USP), 120 mg., Rx only, packaged in 100 tablet bottle containers. Product label contains NDC 0456-0461-01 (FOREST). 
CODE
a) Lots 034052, 035064, 035066, 036171, and 036456;
b) Lots 034053, 034488, 035065, 035997, 036500, 040423;
c) Lots 034051, 035067, 035995, 035996, 036499, 042018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH
Manufacturer: Forest Pharmaceuticals, Inc., Earth City, MO. 
REASON Subpotent: Product may not maintain potency throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE 58,544/100 tablet bottles.
DISTRIBUTION Nationwide.

McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide Recall of Children's Tylenol Meltaways - 80 Mg, Children's Tylenol Softchews - 80 Mg and Jr. Tylenol Meltaways - 160 Mg

McNeil Consumer & Specialty Pharmaceuticals is voluntarily recalling all lots and all flavors of Children's TYLENOL® Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOL®SoftChews 80mg packaged in blisters, and Junior TYLENOL® Meltaways 160mg packaged in blisters. The blister package design, as well as the information on the blister package and on the blister and bottle cartons may be confusing and could lead to improper dosing, including over-dosing.

Some Children's TYLENOL® Meltaways 80mg and Children's TYLENOL® SoftChews 80mg are packaged in a blister package designed to be convenient for parents who need dosing flexibility depending on the age or weight of the child. The package design includes blister cavities that contain one tablet while other cavities contain two tablets. Concerns have been raised that labeling on the carton and on the back of the two-tablet cavities may erroneously suggest to the consumer that two tablets provide a total of 80mg of the active ingredient, acetaminophen, when two tablets would actually provide 160mg of acetaminophen. Consumers should know that each tablet of Children's TYLENOL Meltaways and Children's TYLENOL SoftChews contains 80 mg of this active ingredient. Each tablet is imprinted with the number "80" to reflect this amount. Caregivers should be guided by the dosage directions in the "Drug Facts" labeling on the carton for the correct number of individual tablets to be given based on the child's age and weight.

In addition, some Children's TYLENOL® Meltaways 80mg are packaged in a bottle. The bottle is packaged in a carton. Concerns have been raised that the information on the front panel of the carton for Children's TYLENOL® Meltaways 80mg may be confusing to some consumers in determining the proper dosage. The carton labeling says that each dose provides 80 mg of acetaminophen. Consumers should know that each tablet of Children's TYLENOL Meltaways contains 80 mg of acetaminophen. Caregivers should be guided by the dosage directions on the bottle label for the correct number of individual tablets to be given based on the child's age and weight.

Concerns have also been raised that the carton labeling for Junior TYLENOL® Meltaways 160mg may be confusing to some consumers in determining the proper dosage. This labeling says that each dose provides 160 mg of acetaminophen. Consumers should know that each tablet of Junior TYLENOL Meltaways contains 160 mg of acetaminophen. Caregivers should be guided by the dosage directions in the "Drug Facts" labeling on the carton for the correct number of individual tablets to be given based on the child's age and weight.

Taking more than the recommended dose (overdose) of acetaminophen may cause liver damage when taking the product for fever or pain relief over the course of the three- or five-day period specified by the labeling.

McNeil is working with the U.S. Food and Drug Administration in this recall and in the effort to alert consumers and retailers nationwide about this issue. Consumers or retailers who have questions or concerns about a product described in this alert should contact McNeil's Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish) or visit www.TYLENOL.com. The website contains written material and photos of the product and the packaging. Any adverse reactions experienced with the use of these products should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/

WEEK ENDING JUNE 11

PRODUCT
A) Nefazodone HCl Tablets, 50mg, bottles of 60, 100, and unit dose cartons of 100, Rx only, ***** NDC 0172-4343- 49. 
b) Nefazodone HCl Tablets, 100mg, bottles of 60, 100, and 500 and unit dose cartons of 100, Rx only, *****NDC 0172-4332-49. 
c) Nefazodone HCl Tablets, 150mg, bottles of 60, 100, and 500 and unit dose cartons of 100, Rx only, **** NDC 0172-4333-49. 
d) Nefazodone HCl Tablets, 200mg, bottles of 60, 100, and 500 and unit dose cartons of 100, Rx only, ***** NDC 0172-4334-49. 
e) Nefazodone HCl Tablets, 250mg, bottles of 60 and 100, Rx only, ***** NDC 0172-4335-49. 
CODE
a) Lot Number 122321, exp. 01/2006; 120257, exp. 12/2005; 120720, exp. 01/2006; 118544, exp. 06/2005; 118545, exp. 06/2005; 118557, exp. 06/2005; 118557A, exp. 06/2005;
b) Lot Number 120712, exp. 12/2005; 118550, exp. 07/2005; 120236, exp. 10/2005; 118540, exp. 06/2005; 118546, exp. 06/2005;
c) Lot Number 125021, exp. 03/2006; 120237A, exp. 09/2005; 122816, exp. 01/2006; 120238, exp. 09/2005; 118541, exp. 06/2005; 118547, exp. 06/2005; 118551, exp. 06/2005; 120237, exp. 09/2005; 118552, exp. 06/2005;
d) Lot Number 120252, exp. 12/2005; 120714, exp. 03/2006; 120253, exp, 12/2005; 120251, exp. 10/2005; 118542, exp. 06/2005; 118548, exp. 06/2005; 118553, exp. 07/2005; 118554, exp. 07/2005; 118556, exp. 07/2005; 120250, exp. 10/2005; 118555, exp. 07/2005;
e) Lot Number 120255A, exp. 10/2005; 120255, exp. 10/2005; 118543, exp. 05/2005; 118549, exp. 06/2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL
Manufacturer: Ivax Pharmaceuticals Inc, Northvale, NJ. 
REASON Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE 412,350 bottles
DISTRIBUTION Nationwide

WEEK ENDING JUNE 18

PRODUCT Zanosar Sterile Powder for Injection (streptozocin sterile powder), 1 gm Single Dose Vial, For Intravenous Use Only, Rx only. NDC 0703-4636-01. 
CODE Lot 04K901 EXP 12/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health Inc., Columbus, OH, 
Manufacturer: Sicor Pharmaceuticals, Inc., Irvin, CA. 
REASON Degradation: product stored at uncontrolled temperature
VOLUME OF PRODUCT IN COMMERCE 59 vials
DISTRIBUTION WA and FL

PRODUCT Ranitidine HC1, 150mg, USP, 30 count bottles, Rx only, NDC #67544027830. 
CODE Batch number H21685, Lot number GP7746J
RECALLING FIRM/MANUFACTURER PrePak Systems Inc., Cookeville, TN
REASON Adulterated: A complaint was received from a patient stating that there was a foreign pill in his sealed prescription bottle of ranitidine.
VOLUME OF PRODUCT IN COMMERCE 2,501 bottles of 30
DISTRIBUTION IL

PRODUCT
a) LAMICTALÆ Tablets, (lamotrigine), 25mg/100mg Dose Escalation Sample Packs (Green), 20 unit blister packs, Each Escalation pack contains 84/25 mg tablets for use in weeks 1-4 of treatment and 14/100mg tablets for use in week 5 of treatment, Rx only, NDC 0173-0594-00.
b) LAMICTALÆ Tablets (lamotrigine), 25mg/100mg Bipolar Sample Kit (Orange), 20 units blister packs, Each escalation pack contains 42/25mg tablets for use in weeks 1-4 of treatment, Rx only, **** NDC 0173-0594-03.
CODE
a) Lot #2ZP1447A, 2ZP1496, 2ZP1697, 2ZP2109, 2ZP2110, 2ZP2111, 3ZP0032, 3ZP0033, 3ZP0310B, 3ZP0618A, 3ZP0618B, 3ZP0620A, 3ZP1260, 3ZP1410, 3ZP0310A;
b) Lot #3ZP0159A, 3ZP0620B, 3ZP1072A, 3ZP1072B, 3ZP1072C, 3ZP1072D, 3ZP1072E, 3ZP1072ER, 3ZP1613, 3ZP1732, 3ZP1733, 3ZP1889, 3ZP1890, 3ZP2227, 3ZP2228, 3ZP2614,
3ZP2614A, 4ZP1049B, 4ZP1470A, 4ZP1626A, 4ZP219A, 4ZP8181A, 4ZP8183A, 4ZP1049A
RECALLING FIRM/MANUFACTURER GlaxoSmithKline, Inc, Zebulon, NC,
REASON Mispacked; The week 5 treatment package may contain 25mg tablets instead of 100mg tablets.
VOLUME OF PRODUCT IN COMMERCE 1,406,738 units
DISTRIBUTION Nationwide

PRODUCT Reyataz Capsules (atazanavir sulfate) 100 mg capsules in 60 count bottles, Rx only, NDC 0003-3623-12. 
CODE Lot 5A3117A; Exp. Jan 2008
RECALLING FIRM/MANUFACTURER Bristol Myers Squib Co, Evansville, IN\
REASON Mislabeled; expiration date incorrectly declared as 2008 instead of 2007.
VOLUME OF PRODUCT IN COMMERCE 700 bottles
DISTRIBUTION Nationwide

Quality Care Products L.L.C. Able Laboratories Inc. Nationwide Recall

Quality Care Products, LLC, Temperance, MI, a federally licensed drug re-packager  initiating a nationwide recall of any and all numbers they repackaged from drugs that were manufactured by Able Laboratories Inc., Cranbury, NJ. This recall is due to Able Laboratories voluntary recall of all of their drug products.

The Agency recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their health care provider. In many cases the risk of suddenly stopping needed medication before getting replacement drugs may outweigh the risk of continuing to use the recalled products.

The list below provides the names of the recalled drugs and their imprint codes. Imprints are marks (usually letters and numbers) found on the surface of a capsule and or tablet. If you have one of the drugs listed below with one of the corresponding imprint codes, your drug is covered by the Quality Care Products recall. Liquid products that are being recalled can be identified by the lot numbers printed on their packaging.

It is important to note that this recall only applies to the drugs produced by Able Laboratories -- and not to the same drugs produced by other manufacturers.

The recall includes the following:

  These products were distributed to Physician office dispensaries in over 12 States. A copy of a sample label is attached to help you to identify these products.

The company has already notified all of their Physician dispensaries via letter, and has arranged for a replacement of all full or partially filled bottles. Consumers with questions may contact the company via e-mail at consumer@qcpmeds.com or call 800-337-8603 between the hours of 8am to 5pm EST.

Bioniche Issues Recall of BetacTM

  June 17, 2005 -- Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the Canadian arm of its Pharma Division (Bioniche Pharma Canada Limited) is initiating a Class 1 recall of BetacTM, (NDC 62086-139-50/DIN 02245625), an injectable ascorbic acid product that is produced at the Bioniche Pharma Group Limited’s sterile injectable manufacturing facility in Galway, Ireland.

Approximately one-third of the product released to the market has been found to contain visible particulate matter (microbial in origin) which could potentially result in serious adverse health reactions. 

Contact information:

U.S. health care professionals

Call Bioniche Life Sciences at 1-888-258-4199 or FDA’s MedWatch program at 1-800-FDA-1088 Contact the FDA via the MedWatch website at http://www.fda.gov/medwatch/, or by mail (using postage-paid form) to MedWatch, HFD-410, 5600 Fishers Lane, Rockville, MD 20857-9787.

Canadian health care professionals

Call Bioniche Life Sciences at 1-888-258-4199 or the Adverse Drug Reaction Centre of Health Canada at 1-866-234-2345.

Bioniche Pharma voluntarily recalled all lots of the product after learning about the issue. The product is sold to pharmacies and clinics, either directly or through distributors. All recipients have been notified by phone and fax.

WEEK ENDING JUNE 25

PRODUCT MAGNESIUM SULFATE 40 g (80 ml of 50% Injection) added to 1000 ml Lactated Ringers” Injection USP C.O.M.P.A.S.S. is a Compounding Service of NDC Code: 61553-408-04. 
CODE Lot #: 04011428 Expiration date: 2/28/04
RECALLING FIRM/MANUFACTURER PharMedium Services, Llc, Houston, TX
REASON Presence of particulate matter
VOLUME OF PRODUCT IN COMMERCE 120 bags
DISTRIBUTION Nationwide

PRODUCT MAGNESIUM SULFATE 1 g (2 ml of 50% Injection) added to 50 ml 5% Dextrose Injection USP C.O.M.P.A.S.S. is a Compounding Service of PharMedium Services. NDC Code: 61553-410-41. 
CODE Lot #: 04013008 Expiration date: 3/15/04
RECALLING FIRM/MANUFACTURER PharMedium Services, Llc, Houston, TX
REASON Mislabeling
VOLUME OF PRODUCT IN COMMERCE 240 units
DISTRIBUTION Nationwide