Drug product
Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
D-0192-2024
Product summary
- Event
- Event 89450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
drug-enforcement:D-0192-2024
Official wording
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Code information: Batch 400454
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations