Drug Enforcement D-408-2014

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

May 11, 2016

Product Information

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
Product quantity
30,264 bottles
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
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-408-2014
Event ID
66345
Recall initiation date
September 17, 2013
Center classification date
January 10, 2014
Code info
Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
More code info
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