Unichem recalls 1 lot of blood pressure drug

August 6, 2015

Unichem Pharmaceuticals issued a voluntary recall of Hydrochlorothiazide Tablets 25 mg, 1,000-count bottle. The precautionary measure is due to the identification of a Clopidogrel tablet found in a bottle at one pharmacy.

Unichem Pharmaceuticals in Rochelle Park, N.J., is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg, 1,000-count bottle at the consumer level. The recall is a precautionary measure, due to the identification of a clopidogrel tablet found in a bottle of the product at one pharmacy. Hydrochlorothiazide is indicated for the management of high blood pressure and edema.

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“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,” according to a Unichem statement. In addition, patients with active bleeding or who are allergic to clopidogrel or any component of the formulation may experience more serious adverse health consequences.

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Patients who miss a dose of Hydrochlorothiazide could experience uncontrolled blood pressure or swelling caused by excess fluid (edema). “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,” the company stated.

However, according to Unichem's internal investigation, this is an isolated event noted at one pharmacy and is confined to the recalled lot. “Unichem has not received any reports of adverse events related to this recall to date,” the company stated.

The affected Hydrochlorothiazide tablets include the Lot # GHYL15028 - Expiration April, 2018, which was distributed nationwide directly to wholesalers, retailers, and pharmacies from May 21 through 28, 2015.

Consumers with questions about the recall can contact Unichem Pharmaceuticals by e-mail, regaffairs@unichemusa.com, or call customer service at (866) 931-0704. Adverse reactions or quality problems may be reported to FDA's MedWatch Adverse Event Reporting program.

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