January 28, 2021
American Health Packaging is recalling a single lot of nitrofurantoin capsules because samples failed to meet dissolution specifications during testing, according to the January 27, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 1948 cartons of nitrofurantoin capsules (monohydrate/macrocrystals), 100 mg, 100 per carton (blister card NDC 68084-446-11, carton NDC 68084-446-01), from lot 193757 (Exp 1/31/22). The product was distributed throughout the United States.
American Health Packaging voluntarily initiated the recall January 7, 2021. On January 15, 2021, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Nitrofurantoin is a prescription antibiotic medication used to treat urinary tract infections.