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Sun Pharma, Glenmark recall products due to manufacturing issues

New Delhi: Due to flaws in the manufacturing process, top pharmaceutical companies Sun Pharma and Glenmark are recalling products in the US, which is the world’s largest market for pharmaceuticals. According to the US Food and Drug Administration’s (USFDA’s) most recent enforcement report, a US-based Sun Pharma division is recalling 50,680 vials of Testosterone Cypionate […]

Edited By : Vikas Kumar | Updated: Jul 24, 2022 17:45 IST
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New Delhi: Due to flaws in the manufacturing process, top pharmaceutical companies Sun Pharma and Glenmark are recalling products in the US, which is the world’s largest market for pharmaceuticals.

According to the US Food and Drug Administration’s (USFDA’s) most recent enforcement report, a US-based Sun Pharma division is recalling 50,680 vials of Testosterone Cypionate Injection, which is used to treat low testosterone in adult males.

The Mumbai-based pharmaceutical company is recalling the concerned batch because “water leakage” caused a divergence from the industry’s current good manufacturing procedures, according to the US health authorities (cGMP).

Due to cGMP deviations, the company is also recalling 27 vials of the same drug, according to the USFDA.

“Manufacturing deviations were reported due to an abnormal appearance on parts of machinery,” it added. The impacted lot was created at the Sun Pharma manufacturing facility in Halol, Gujarat.

Sun Pharmaceutical Industries Inc, a division of the business with headquarters in New Jersey, began the Class II US-wide recall of the concerned lots last month.

According to the USFDA, a class II recall is started when using or being exposed to a product that is in violation may result in short-term or medically treatable adverse health effects or when the likelihood of substantial adverse health effects is remote.

Glenmark, a company with its headquarters in Mumbai, is recalling 98,307 packets of Mometasone Furoate Topical Solution, a drug used to treat eczema, psoriasis, allergies, and rash.

According to the USFDA, the lot that was shipped from Glenmark Pharmaceuticals Inc.’s Baddi (Himachal Pradesh) factory is being recalled because of “Defective Container.”

On June 16, the business began the extensive recall, which the US health watchdog categorised as Class III.

When using or being exposed to a product that violates the law is unlikely to have a negative impact on one’s health, a Class III recall is issued.

In 2019, it was predicted that the US generic medication market would be worth about USD 115.2 billion. It is unquestionably the world’s largest market for pharmaceutical goods.

First published on: Jul 24, 2022 05:45 PM IST

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