Amneal Pharma recalling three lots of urinary tract infection tablets in U.S.

Amneal Pharmaceutical is recalling three lots of urinary tract infection drug Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg in the U.S. due to microbial contamination.

The recall is to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint, U.S. Food and Drug Administration said on the nationwide recall announcement of Amneal Pharmaceutical LLC.

Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg is packaged in 100 tablet count and 500 tablet count bottles. The recall pertains only to the 400 mg/80 mg strength and the three lots. Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall, the U.S. FDA said.