FDA recall D-317-2013

Physicians Total Care, Inc. · Class III · drug

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.

Reason for recall

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

Distribution

Key facts

Status: Terminated
Initiation date: 2011-02-08
Report date: 2013-05-15
Termination date: 2013-07-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-317-2013