Drug product
Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17
D-1516-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1516-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: Lot #: 18252, 19033, Exp. Date: 10/20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations