PlainRecalls
FDA Drug Moderate Class II Terminated

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58

Reported: March 25, 2020 Initiated: October 23, 2019 #D-1020-2020

Product Description

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58

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, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58. 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-1020-2020.