Multi-event September 2013 FDA Recall Quinapril by Lupin Pharmaceuticals Inc.
This Multi-event Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on September 17, 2013 for the product Quinapril. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-409-2014
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
09-17-2013
01-22-2014
22, 896 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
05-11-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot 3110358 Exp. 12/13
Affected Packages Involved in this Recall
Recall Number: 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
09-17-2013
01-22-2014
30,264 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
05-11-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
