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Indian pharma firms Zydus, Alembic recall 2 drugs in US over ‘life-threatening’ consequences

Zydus Cadila recalls injection for treatment of herpes infections over complaints of crystallisation in vials, Alembic Pharmaceuticals recalls its high BP drug due to labelling error.

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New Delhi: Two Indian pharmaceutical companies, Zydus Cadila and Alembic Pharmaceuticals, are recalling drugs in the US after receiving complaints about their products.

Both recalls have been termed as having the potential of being “life threatening”.

According to the United States Food and Drug Administration (US FDA), the Gujarat-based Alembic Pharmaceuticals’ US subsidiary is voluntarily recalling its high blood pressure drug, telmisartan, due to a mislabelling error.

The company has received complaints that the bottles labelled for 20 mg tablets contain 40 mg tablets. However, the company has clarified that the 20 mg tablets are round and 40 mg tablets are oval in shape.

Zydus Pharmaceuticals (USA), an arm of Indian drugmaker Zydus Cadila, has also announced voluntary recall of acyclovir sodium injection, which is used for the treatment of herpes infections in immunocompromised patients, after receiving several complaints of crystallisation in vials.

A senior official at India’s apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), told ThePrint that the office is checking with both the companies regarding the status of similar products sold in India. “We regularly keep a check on international developments and reach out to companies to seek information about the status in the Indian market. There is no cause of concern and we are in touch with both the companies.”

ThePrint reached Zydus Cadila and Alembic Pharmaceuticals via email for a comment but did not get any response until the time of publishing this report.

Also read: In a first, Modi govt forms panel to study business of AYUSH products, therapies in India

‘Life-threatening’ consequences

According to the US FDA, both companies announced “voluntary recall” of the drugs on 24 March.

According to Zydus Pharmaceuticals (USA) Inc’s announcement published on the US FDA’s website, “Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences…”

The consequences include “injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells”, it said.

However, the company has clarified that it “has not received any reports of adverse events related to this product recall”.

The announcement by Alembic, which recalled telmisartan, said high blood pressure drug can impact “patients who could be on a doubled dose of telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening”.

The company also clarified that “Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall”.

It has also announced that “the wrong product can be identified by checking the shape and embossing details on the tablets…”

(Edited by Neha Mahajan)

Also read: Hospitalised Covid patients on some cholesterol drugs half as likely to die, finds study


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