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Recall Observatory FDA recall evidence

Drug 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

D-1450-2014

September 27, 2011

Class II

Product summary

Firm
Shamrock Medical Solutions Group LLC
Event
Event 64611
Status
Terminated
Classification
Class II
Quantity
284/800 mg tablets
Official record key
drug-enforcement:D-1450-2014

Official wording

Reason: 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

Code information: Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01

Distribution pattern: Product was shipped to the following states: CO, MA, OH, TX & WY.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix up