Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
Menthocin Patch with Lidocaine-Strong
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an approved NDA/ANDA
What was recalled
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
- Recalling firm
- Bonita Pharmaceuticals, LLC
- NDC code
- 53598-0012-15
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0665-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Lidocaine recalls
See all
Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk Ongoing
Lidocaine HCl Injection
Reason Presence of Particulate Matter: Hair was found in products
Class III · Low risk Ongoing
Lidolog Kit
Reason Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class II · Moderate risk Ongoing
Lidocaine HCl Injection USP
Reason Lack of Assurance of Sterility
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