Drug product
Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09
D-408-2014
Product summary
- Event
- Event 66345
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,264 bottles
- Official record key
drug-enforcement:D-408-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Code information: Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications