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Subpotent Antibiotic Recalled


September 18, 2020

Teva Pharmaceuticals is recalling 38,487 bottles of cephalexin for oral suspension after samples of the drug tested below specification for potency. The recall was included in the September 16, 2020, US Food and Drug Administration (FDA) Enforcement Report.  

The recall affects cephalexin for oral suspension, 250 mg per 5 mL, for reconstitution, for oral use, 100-mL bottle when mixed (NDC 0093-4177-73), from lot 30310638A (Exp. 1/22). The product was distributed throughout the United States and Puerto Rico. 

Teva Pharmaceuticals voluntarily initiated the recall August 24, 2020. On September 10, 2020, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Cephalexin is a prescription antibiotic used to treat a wide variety of bacterial infections.  

Jolynn Tumolo

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