Drug 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.
D-1278-2020
Product summary
- Event
- Event 85726
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 54,000 boxes
- Official record key
drug-enforcement:D-1278-2020
Official wording
Reason: CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Code information: Batch #: 170527, Exp 2020.05
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations