FDAClass IIAugust 21, 2019

CVS Therapeutic Menthol Gel recall: CGMP Deviations

CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3

Why was CVS Therapeutic Menthol Gel recalled?

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

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?

Lot #'s 28L17, 31L17, 36L17, 40L17, 44L17 EXP 09/2019; 05M17, 09M17, 12M17, 13M17, 23M17 EXP 10/2019; 69P17, 72P17 EXP 11/2019; 42S17, 46S17 EXP 12/2019; 85C18, 86C18 EXP 03/2020; 31J18, 43J18, 55J18, 58J18, 18L18 EXP 07/2020.

Product
CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
Recalling firm
US Pharmaceuticals Inc.
Quantity
5017 cases
Distribution
Distributed Nationwide in the USA
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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