Drug product
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
D-0166-2024
Product summary
- Event
- Event 89450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
drug-enforcement:D-0166-2024
Official wording
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Code information: Batch LJ9004
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations