Drug product
Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13
D-1520-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1520-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: Lot #: 19234; Exp. Date: 9/20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations