LidoPro Patches Recalled Due to Missing Manufacturing Records
Wuhan Bingbing Pharmaceutical is recalling LidoPro patches because manufacturing records and samples were lost, preventing verification of product stability.
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, but the source text does not report any illnesses or injuries. The hazard is a theoretical risk regarding product stability due to missing records, which aligns with the rubric for moderate severity involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Wuhan Bingbing Pharmaceutical Co., Ltd. is recalling 54,000 boxes of LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patches. The product is manufactured for Terrain Pharmaceuticals and was distributed nationwide in the USA. The specific batch number is 170527, with an expiration date of May 2020.
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 this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- 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.
- Manufacturer
- Wuhan Bingbing Pharmaceutical Co., Ltd.
- Category
- Drug — Topical Analgesic
- Affected units
- 54,000
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 (2)
- Batch #: 170527
- Exp 2020.05
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.
See all 4 products in this recall →Related recalls
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