Drug product
Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
D-1532-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1532-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: Lot #: a) 19271, Exp. Date 10/20 b) 19206, 19209B, Exp. Date 08/20; 19229, Exp. Date 10/20; 19255, Exp. Date 09/20; 19271, Exp. Date 08/20; 19301, Exp. Date 10/20; 19327, Exp. Date 11/20; 19336, Exp. 12/20; 20012, Exp. Date 1/21; 20045, Exp. Date 2/21.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations