Mencaine Patch recalled over manufacturing violations

Recall date

May 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Wuhan Bingbing Pharmaceutical Co., Ltd. recalls Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 895…

Recall number

D-1279-2020

FDA classification

Class II

Brand / firm

Wuhan Bingbing Pharmaceutical Co., Ltd.

Sold / distributed

Nationwide in the USA

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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