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Recall Observatory FDA recall evidence

Drug product

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

D-1279-2020

May 19, 2020

Class II

Product summary

Firm
Wuhan Bingbing Pharmaceutical Co., Ltd.
Event
Event 85726
Status
Ongoing
Classification
Class II
Quantity
1,800 pouches
Official record key
drug-enforcement:D-1279-2020

Official wording

Reason: 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.

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations