Drug product
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
D-0572-2016
Product summary
- Event
- Event 72382
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9526
- Official record key
drug-enforcement:D-0572-2016
Official wording
Reason: Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Code information: Lot # 6727001 Exp 01/18
Distribution pattern: MS
Derived failure modes
-
Foreign material or chemical contamination
foreign substance