Maximum 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 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 011…

Recall number

D-1028-2020

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

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82