Drug product
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
D-1515-2020
Product summary
- Event
- Event 86123
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1515-2020
Official wording
Reason: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Code information: Lot #: 19260H; Exp. Date: 1/21
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations