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, 24 tablets per bottle. [Brand, NDC] NDC Care O…

Recall number

D-1019-2020

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, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02