FDA recall D-1450-2014

Shamrock Medical Solutions Group LLC · Class II · 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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2011-09-27
Report date: 2014-07-30
Termination date: 2014-07-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lewis Center, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1450-2014