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
Reported: January 22, 2014 Initiated: September 17, 2013 #D-408-2014
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 30,264 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 30,264 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-408-2014.
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