Drug product
Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
D-1523-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1523-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: Lot #: 19169; Exp. Date: 7/20, 08/20, 09/20; 19237, Exp. Date: 10/20, 11/20, 12/20; 19331, Exp. Date: 12/20; 20031, Exp. Date: 3/21
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations