Drug product
Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
D-1514-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1514-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: Lot #: 19355; Exp. Date: 3/21
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations