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Recall Observatory FDA recall evidence

Drug product

LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.

D-1278-2020

May 19, 2020

Class II

Product summary

Firm
Wuhan Bingbing Pharmaceutical Co., Ltd.
Event
Event 85726
Status
Ongoing
Classification
Class II
Quantity
54,000 boxes
Official record key
drug-enforcement:D-1278-2020

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 #: 170527, Exp 2020.05

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations