Drug product
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
D-393-2014
Product summary
- Firm
- Sandoz Inc
- Event
- Event 66554
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,491 bottles of 100 tablets each
- Official record key
drug-enforcement:D-393-2014
Official wording
Reason: Subpotent; Hydrochlorothiazide at the 9 month time point.
Code information: Lot CU0856
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent