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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

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
Recall Number D-409-2014
Classification Class II
Code Info Lot 3110358 Exp. 12/13
Product Distributed Qty 22, 896 bottles
Reason For Recall Failed Impurity/Degradation Specification: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Event Detail

Event Id 66345
Product Type Drugs
Status Ongoing
Recalling Firm Lupin Pharmaceuticals Inc.
City Baltimore
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico