Recalls / Class II
Class IID-1450-2014
Product
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01
- Brand name
- Sulfamethoxazole And Trimethoprim
- Generic name
- Sulfamethoxazole And Trimethoprim
- Active ingredients
- Sulfamethoxazole, Trimethoprim
- Route
- Oral
- NDCs
- 53746-271, 53746-272
- FDA application
- ANDA076899
- Affected lot / code info
- Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01
Why it was recalled
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Recalling firm
- Firm
- Shamrock Medical Solutions Group LLC
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 741 Radio Dr, Lewis Center, Ohio 43035-7134
Distribution
- Quantity
- 284/800 mg tablets
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
Timeline
- Recall initiated
- 2011-09-27
- FDA classified
- 2014-07-23
- Posted by FDA
- 2014-07-30
- Terminated
- 2014-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1450-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.