FDA Drug Recalls

Recalls / Class III

Class IIID-317-2013

Product

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.

Affected lot / code info
Lot # 67JV Exp 08/13

Why it was recalled

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

Recalling firm

Firm
Physicians Total Care, Inc.
Notification channel
FAX
Type
Voluntary: Firm initiated
Address
12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234

Distribution

Quantity
60 tablets
Distribution pattern
NC

Timeline

Recall initiated
2011-02-08
FDA classified
2013-05-09
Posted by FDA
2013-05-15
Terminated
2013-07-01
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-317-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.