July 2015 FDA Recall Hydrochlorothiazide by Unichem Pharmaceuticals Usa Inc
D-1352-2015 - Presence of Foreign Tablet
This Class II drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc on July 30, 2015 for the product Hydrochlorothiazide. The FDA reported the reason for recall as presence of foreign tablet. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1352-2015
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
07-30-2015
09-02-2015
4776 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.
Unichem Pharmaceuticals Usa 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
Batch or Lot Expiration Information
Lot# : GHYL15028, Exp April 2018
