Ranitidine Capsules 300 mg recalled over manufacturing violations

Recall date

January 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Appco Pharma LLC recalls Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distrib…

Recall number

D-0648-2020

FDA classification

Class II

Brand / firm

Appco Pharma LLC

Sold / distributed

Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.

Why it was recalled

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.