Ranitidine Syrup recalled over manufacturing violations

Recall date

November 1, 2019

Source

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

Official notice title

American Health Packaging recalls Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Heal…

Recall number

D-0631-2020

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

Nationwide USA

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

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 Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)