Drug product
Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940; NDC 10702-0028-10
D-1528-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1528-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: Lot #: a)19290, Exp. Date: 10/20; b) 19224; Exp. Date: 08/20; 19249, Exp. Date: 09/20; 19290, Exp. Date: 10/20; 19322, Exp. Date: 12/20; 20013, Exp. Date: 01/21; 20039, Exp. Date: 02/21 c) 19290, Exp. Date: 10/20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations