Bonita Pharmaceuticals Recalls Menthocin Patch with Lidocaine-Strong
Bonita Pharmaceuticals is recalling Menthocin Patch with Lidocaine-Strong because it was marketed without an approved NDA or ANDA.
What this means for you
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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The primary issue is regulatory (lack of approval) rather than a specific reported injury or contamination event.
Plain-English summary
Bonita Pharmaceuticals, LLC is recalling Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%). The product is packaged in boxes of 15 patches and is marked as prescription only. The specific lot number is 20150326, with an expiration date of 03/2018.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This regulatory deficiency means the product's safety and efficacy have not been fully evaluated and approved by the FDA for its intended use.
Approximately 3,308 boxes of the affected product were distributed nationwide. Consumers and healthcare providers should stop using the recalled patches and contact their healthcare provider for guidance on alternative treatments. The product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15
- Manufacturer
- Bonita Pharmaceuticals, LLC
- Category
- Drug — Topical Analgesic
- Hazard
- Affected units
- 3,308
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)
- Lot#: 20150326
- Exp 03/2018
Distribution
Distributed nationwide across the United States.
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