Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-…

Recall date

September 24, 2019

Source

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

Recall number

D-0318-2020

FDA classification

Class II

Brand / firm

Apotex Inc.

Sold / distributed

Nationwide

Why it was recalled

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

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

What was recalled

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716