FDAClass IIJune 3, 2020

Mencaine recall: CGMP Deviations

Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.

Why was Mencaine recalled?

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Batch #: 170731, Exp 2020.07; 180504; Exp 2021.05

Product
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
Recalling firm
Wuhan Bingbing Pharmaceutical Co., Ltd.
Quantity
1,800 pouches
Distribution
Nationwide in the USA
Recall date
June 3, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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