PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 25, 2020 Initiated: October 23, 2019 #D-1028-2020

Product Description

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

Reason for Recall

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Details

Recalling Firm
Perrigo Company PLC
Distribution
Nationwide USA
Location
Allegan, MI

Frequently Asked Questions

What product 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. Recalled by Perrigo Company PLC.
Why was this product recalled?
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 25, 2020. Severity: Moderate. Recall number: D-1028-2020.