D-409-2014 Class II Terminated
FDA drug recall D-409-2014 was initiated by Lupin Pharmaceuticals Inc. on Sep 17, 2013 and is designated Class II. 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 The recall status is terminated (terminated May 11, 2016). Affected quantity: 22, 896 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 22, 2014
- Initiation Date
- Sep 17, 2013
- Termination Date
- May 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22, 896 bottles
Product Description
Quinapril Tablets USP, 10 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 68180-557-09
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
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 3110358 Exp. 12/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-409-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026