Drug recall
Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%)…
FDA recall event 73174 · Class II · Bonita Pharmaceuticals, LLC
Key facts
| Event ID | 73174 |
|---|---|
| Recall numbers | D-0665-2016 |
| Recalling firm | Bonita Pharmaceuticals, LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without an approved NDA/ANDA |
| Initiation date | Jan 27, 2016 |
| Report date | Feb 24, 2016 |
| Termination date | Mar 6, 2019 |
| City | Westland |
| State | MI |
| Country | United States |
| FEI number | 3009798548 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: