April 2016 FDA Recall Lisinopril And Hydrochlorothiazide by Lupin Pharmaceuticals Inc.
D-1052-2016 - CGMP Deviations
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on April 4, 2016 for the product Lisinopril And Hydrochlorothiazide. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1052-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
04-04-2016
07-06-2016
59,520 Bottles
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 and Puerto Rico
06-01-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Batch or Lot Expiration Information
Lot# : a) H303459, b) H303460, Exp 09/2016
