Drug recall D-409-2014
Product
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
Lots and codes
Lot 3110358 Exp. 12/13
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 22, 896 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 17, 2013
- Terminated
- May 11, 2016
Related products
- Quinapril – drug information
- NDC 68180-554 Quinapril · Quinapril Hydrochloride 40 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-558 Quinapril · Quinapril Hydrochloride 20 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-559 Quinapril · Quinapril Hydrochloride 40 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-557 Quinapril · Quinapril Hydrochloride 10 mg/1 · Lupin Pharmaceuticals, Inc.