December 2015 FDA Recall Quinapril by Lupin Pharmaceuticals Inc.
D-0650-2017 - Failed Impurities/Degradation Specifications; Impurity A
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 7, 2015 for the product Quinapril. The FDA reported the reason for recall as failed impurities/degradation specifications; impurity a. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0650-2017
Failed Impurities/Degradation Specifications; Impurity A
12-07-2015
04-12-2017
15,168 bottes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Batch or Lot Expiration Information
Batch# Batch number G303703, exp 3/2016
