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

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Jul 30, 2015, 03:57 ET

ROCHELLE PARK, N.J., July 30, 2015 /PRNewswire/ -- 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.

Hydrochlorothiazide Tablets 25 mg - light orange, circular, flat, beveled, uncoated tablets, with score line having "U" and "128" debossed across the score line on one side and plain on other side. Size: around 7 mm

Clopidogrel Tablet - Light orange/pink circular/concave/unmarked. Size: 9 mm

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.

Product Description

Hydrochlorothiazide Tablets 25 mg
light orange, circular, flat, beveled, uncoated tablets, with score line having "U" and "128" debossed across the score line on one side and plain on other side
Size: around 7 mm

Clopidogrel Tablet
Light orange/pink circular/concave/unmarked
Size: 9 mm

Consumers with questions regarding this recall can contact Unichem Pharmaceuticals (USA), Inc. by e-mail [email protected] 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.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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

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SOURCE Unichem Pharmaceuticals (USA), Inc.