Drug product
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
D-1279-2020
Product summary
- Event
- Event 85726
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,800 pouches
- Official record key
drug-enforcement:D-1279-2020
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 #: 170731, Exp 2020.07; 180504; Exp 2021.05
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations