Recalls / Class II
Class IID-0572-2016
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
- Affected lot / code info
- Lot # 6727001 Exp 01/18
Why it was recalled
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Recalling firm
- Firm
- Mutual Pharmaceutical Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1100 Orthodox St, N/A, Philadelphia, Pennsylvania 19124-3168
Distribution
- Quantity
- 9526
- Distribution pattern
- MS
Timeline
- Recall initiated
- 2015-10-09
- FDA classified
- 2016-01-19
- Posted by FDA
- 2016-01-27
- Terminated
- 2016-10-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0572-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.