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, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic…

Recall number

D-1023-2020

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, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09