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
Reported: February 24, 2016 Initiated: January 27, 2016 #D-0665-2016
Product Description
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
Reason for Recall
Marketed without an approved NDA/ANDA
Details
- Recalling Firm
- Bonita Pharmaceuticals, LLC
- Units Affected
- 3,308 boxes
- Distribution
- Nationwide
- Location
- Westland, MI
Frequently Asked Questions
What product 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. Recalled by Bonita Pharmaceuticals, LLC. Units affected: 3,308 boxes.
Why was this product recalled? ▼
Marketed without an approved NDA/ANDA
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 24, 2016. Severity: Moderate. Recall number: D-0665-2016.
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