July 2014 FDA Recall Losartan Potassium And Hydrochlorothiazide by Jubilant Cadista Pharmaceuticals Inc.
D-1500-2014 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals Inc. on July 11, 2014 for the product Losartan Potassium And Hydrochlorothiazide. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1500-2014
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
07-11-2014
08-06-2014
9,358 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.
Jubilant Cadista 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
09-15-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
Batch or Lot Expiration Information
Lot# 14P0292, Exp 04/2016
