August 21, 2020
Pharmaceutical Associates Inc. is recalling 7416 bottles of nystatin oral suspension due to subpotency concerns. According to the August 19, 2020, US Food and Drug Administration (FDA) Enforcement Report, out-of-specification results were obtained at the product’s 15-month test interval.
The recall affects nystatin oral suspension, 100,000 units per mL, cherry/peppermint flavor, 16 fluid ounces (473 mL; NDC 0121-0610-16), from lot B973 (Exp. 11/20). The bottles were distributed throughout the United States.
Pharmaceutical Associates Inc. initiated the voluntary recall on August 4, 2020. The FDA designated the recall Class II on August 12, 2020. Under the recall classification, use of the affected product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Nystatin is a prescription antifungal medicine used to treat yeast infections in the mouth or stomach.