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.
D-317-2013
Product summary
- Event
- Event 65004
- Status
- Terminated
- Classification
- Class III
- Quantity
- 60 tablets
- Official record key
drug-enforcement:D-317-2013
Official wording
Reason: Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
Code information: Lot # 67JV Exp 08/13
Distribution pattern: NC
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination