FDAClass IIMarch 25, 2020

Maximum Strength Acid Reducer recall: Impurity Out of Spec

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…

Why was Maximum Strength Acid Reducer recalled?

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: 8FV1462, 8GV1289, 8BE1465, 8CE1616, 8DE1277, 8DE1580, 8DE1766, 8FE1348, 8GE1527, 8GE1733, 8GE1735, 8HE1466, 8HE1590, 8JE2232, 8KE2676, 8LE2283, 8LE2284, 8LE2345, 8ME2640, 9AE2663, 9AE2863, 9AE2864, 9BE3158, 9CE3773, 9CE3774, 9CE3879, 9EE2499, 9EE2635, 9EE2904, 9FE2821, 9FE2953, 9FE3369, 9GE2653, 9GE2905, 9GE3077, 9GE3115, 9HE3546, 9HE3559, 9JE2593

Product
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…
Recalling firm
Perrigo Company PLC
Distribution
Nationwide USA
Recall date
March 25, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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