May 24, 2018
Sun Pharmaceutical Industries Inc. is recalling nearly 2000 bottles of sulfamethoxazole and trimethoprim tablets USP, 800 mg/160 mg (NDC 53489-146-05), after polyethylene was detected in 2 tablets. The recall appears in the May 23, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 500-count bottles from lot 6848501 (Exp. 4/20). The tablets were manufactured by Frontida BioPharm and distributed across the United States by Sun Pharmaceutical Industries.
Sun Pharmaceutical Industries voluntarily issued the recall at the request of the FDA April 19, 2018. On May 11, 2018, the FDA designated it a Class II recall, signaling use of the medication could cause temporary or medically reversible adverse health consequences, with a remote probability of serious harm.
Sulfamethoxazole and trimethoprim tablets are a prescription drug used to treat a variety of bacterial infections, such as ear, urinary, and respiratory infections.
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