October 2015 FDA Recall Irbesartan And Hydrochlorothiazide by Teva Pharmaceutical Industries
D-0521-2016 - Labeling
This Class III drug recall was voluntarily initiated by Teva Pharmaceutical Industries on October 20, 2015 for the product Irbesartan And Hydrochlorothiazide. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0521-2016
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
10-20-2015
12-23-2015
3536 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.
Teva Pharmaceutical Industries
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
11-01-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98
Batch or Lot Expiration Information
Lot# : 24I030, Exp 5/2017
