Drug product
Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
D-1522-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1522-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: a) Lot #: 19236, Exp. Date 10/20 b) Lot #: 19170; 19236, Exp. Date: 09/20; 19303, Exp. Date: 11/20; 19347, Exp. Date: 12/20; 19353, Exp. Date: 01/21: 20032, 20047, Exp. Date: 2/21. c) Lot #: 19236, Exp. Date 10/20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations