Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb...

FDA Drug Recall #D-317-2013 - Class III, February 8, 2011

Recall Summary

Recall Number D-317-2013
Classification Class III, Low risk
Date Initiated February 8, 2011
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Physicians Total Care, Inc.
Location Tulsa, OK
Product Type Drugs
Quantity 60 tablets

Product Description

Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.

Reason for Recall

Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).

Distribution Pattern

NC

Lot / Code Information

Lot # 67JV Exp 08/13

Other Recalls from Physicians Total Care, Inc.

Recall # Classification Product Date
D-0237-2015 Class II CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20... Sep 22, 2014
D-390-2014 Class II Carisoprodol IV ( Carisoprodol Tablets USP) 350... Nov 22, 2013
D-0239-2015 Class III Loratadine 24 HR-OTC,10 mg, 30-count bottle, Ma... Sep 11, 2013
D-826-2013 Class II Belladonna Alkaloids/PB (Belladonna Alkaloids /... Jun 17, 2013
D-499-2013 Class III Camila 0.35 mg Tablets, 6 cards of 28 pills, Di... Mar 18, 2013

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections, all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.