Mencaine Lidocaine Patches Recalled Due to Missing Manufacturing Records
Wuhan Bingbing Pharmaceutical is recalling Mencaine patches because manufacturing records and samples were lost, preventing verification that the product remains within specification through expiration.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a theoretical risk of the product being out of specification due to missing records, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Wuhan Bingbing Pharmaceutical Co., Ltd. is recalling 1,800 pouches of Mencaine (lidocaine 4.5%, menthol 5%) Patches. The product was manufactured for Terrain Pharmaceuticals and distributed nationwide in the USA. The recall involves two specific batches: Batch #170731 (Expiration 2020.07) and Batch #180504 (Expiration 2021.05).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lost product manufacturing records and retained product samples. As a result, there is no assurance that the product will remain within specification through the labeled expiration date.
Consumers who have these specific batches of Mencaine patches should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
- Manufacturer
- Wuhan Bingbing Pharmaceutical Co., Ltd.
- Category
- Drug — Topical Anesthetic
- Affected units
- 1,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batch #: 170731
- Exp 2020.07
- 180504
- Exp 2021.05
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Wuhan Bingbing Pharmaceutical Co., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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