AVKARE Ranitidine Tablets recalled over manufacturing violations

Recall date

November 14, 2019

Source

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

Official notice title

AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal…

Recall number

D-0524-2020

FDA classification

Class II

Brand / firm

AVKARE Inc.

Sold / distributed

Nationwide.

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

AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60