FDA Recall D-1279-2020

Wuhan Bingbing Pharmaceutical Co., Ltd. · Wuhan, N/A

Class II Ongoing 2186 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Batch #: 170731, Exp 2020.07; 180504; Exp 2021.05

Quantity: 1,800 pouches

Reason for recall

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.

Recall record

Recall number: D-1279-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA
Recall initiated: 2020-05-19
Classified by FDA Center: 2020-05-28
FDA published: 2020-06-03
Recalling firm: Wuhan Bingbing Pharmaceutical Co., Ltd.
Firm location: Wuhan, N/A, China

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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