AVKARE product recalled over manufacturing violations

Recall date

October 17, 2019

Source

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

Official notice title

AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for…

Recall number

D-0164-2020

FDA classification

Class II

Brand / firm

AVKARE Inc.

Sold / distributed

CO, MO

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 Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478