Ranitidine Tablets recalled over manufacturing violations

Recall date

November 20, 2019

Source

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

Official notice title

American Health Packaging recalls Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: Amer…

Recall number

D-1003-2020

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

Nationwide USA

Why it was recalled

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

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 Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11