Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Safety

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets

Contact:
Consumer:
1-866-931-0704,
regaffairs@unichemusa.com

FOR IMMEDIATE RELEASE – July 30, 2015 – Rochelle Park, New Jersey – Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product.

The risk associated with mistakenly taking a Clopidogrel tablet instead of a Hydrochlorothiazide tablet is the increased probability of experiencing Clopidogrel's side effects which include bleeding and/or bruising. Patients with active bleeding or who are allergic to Clopidogrel or any component of the formulation may experience more serious adverse health consequences as a result of unknowingly consuming Clopidogrel. Additionally, missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema). As per Unichem's internal investigation, this episode is an isolated event noted at one pharmacy and confined to the recalled lot. Unichem has not received any reports of adverse events related to this recall to date.

Hydrochlorothiazide tablets are indicated for the management of high blood pressure and edema and are packaged in 1000-count bottles. The affected Hydrochlorothiazide tablets include Lot # GHYL15028 - Expiration April, 2018, and was distributed nationwide directly to wholesalers, retailers, and pharmacies from May 21 - 28, 2015.

Unichem is notifying its distributors and customers by letter, overnight FedEx and emails. Unichem is also arranging for return of all recalled products. Consumers should not consume Hydrochlorothiazide Tablets 25 mg 1000's from the lot GHYL15028 which is being recalled and should return to place of purchase.

Consumers with questions regarding this recall can contact Unichem Pharmaceuticals (USA), Inc. by e-mail regaffairs@unichemusa.com or call customer service at: 1-866-931-0704, Monday through Friday 8:30 AM - 5:00 PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. If the consumer is not sure they received the recalled lot, they should contact the pharmacy that dispensed the product to them.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

RSS Feed for FDA Recalls Information [what’s this?]

Photo: Product Labels

Recalled Product Photos Are Also Available on FDA’s Flickr Photostream.

Page Last Updated: 07/31/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English