Unichem recalls a lot of hypertension drug in US
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New Delhi, Aug 3 : Drug firm Unichem Laboratories is recalling one lot of Hydrochlorothiazide tablets, used to treat high blood pressure, in the US market due to the identification of another tablet in a bottle of the product.
Unichem Pharmaceuticals (USA), Inc, a wholly-owned subsidiary of the company, is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle at the consumer level, US Food and Drug Administration (USFDA) said in a statement.
"This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product," it added.
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, the US health regulator said.
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, it said.
Additionally, missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid, it added.
"As per Unichem's internal investigation, this episode is an isolated event noted at one pharmacy and confined to the recalled lot," USFDA said.
Unichem has not received any reports of adverse events related to this recall to date, it added.
Hydrochlorothiazide tablets are indicated for the management of high blood pressure and edema and are packaged in 1000-count bottles.
The affected lot of Hydrochlorothiazide tablets was distributed nationwide directly to wholesalers, retailers, and pharmacies from May 21-28, 2015.
Unichem Laboratories, started by the late Mr. Amrut Mody in the year 1944, is one of the oldest pharmaceuticals in india, and is headquartered at Mumbai. Unichem Labs has made more than 600 product registrations across the world and more than 500 regulatory filings such as DMFs, EDMFs etc. It has filed 29 US ANDAs of which 15 have been approved with many more still in the pipeline.
Unichem Pharmaceuticals (USA), Inc, a wholly-owned subsidiary of the company, is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle at the consumer level, US Food and Drug Administration (USFDA) said in a statement.
"This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product," it added.
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, the US health regulator said.
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, it said.
Additionally, missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid, it added.
"As per Unichem's internal investigation, this episode is an isolated event noted at one pharmacy and confined to the recalled lot," USFDA said.
Unichem has not received any reports of adverse events related to this recall to date, it added.
Hydrochlorothiazide tablets are indicated for the management of high blood pressure and edema and are packaged in 1000-count bottles.
The affected lot of Hydrochlorothiazide tablets was distributed nationwide directly to wholesalers, retailers, and pharmacies from May 21-28, 2015.
Unichem Laboratories, started by the late Mr. Amrut Mody in the year 1944, is one of the oldest pharmaceuticals in india, and is headquartered at Mumbai. Unichem Labs has made more than 600 product registrations across the world and more than 500 regulatory filings such as DMFs, EDMFs etc. It has filed 29 US ANDAs of which 15 have been approved with many more still in the pipeline.
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