Drug product
Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
D-1406-2015
Product summary
- Event
- Event 71863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,705 bottles
- Official record key
drug-enforcement:D-1406-2015
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # a) C0570215B; Exp 02/17 b) C0570215A; Exp 02/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications