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 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 4…

Recall number

D-0525-2020

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 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30