Drug product
CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10
D-0172-2024
Product summary
- Event
- Event 89450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
drug-enforcement:D-0172-2024
Official wording
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Code information: Batch 2107329UM
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations