Drug product
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
D-0650-2017
Product summary
- Event
- Event 76924
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15,168 bottes
- Official record key
drug-enforcement:D-0650-2017
Official wording
Reason: Failed Impurities/Degradation Specifications; Impurity A
Code information: Batch number G303703, exp 3/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications