Regular Strength Acid Reducer recalled over manufacturing violations

Recall date

October 23, 2019

Source

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

Official notice title

Perrigo Company PLC recalls Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 6201…

Recall number

D-1013-2020

FDA classification

Class II

Brand / firm

Perrigo Company PLC

Sold / distributed

Nationwide USA

Why it was recalled

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;