Sun Pharma recalls pre-filled syringes of infertility drug in US over manufacturing issue

"A piece of glass was found in a prefilled syringe," USFDA said.

Published On 2023-05-08 06:01 GMT | Update On 2023-10-12 11:06 GMT

New Delhi: Drug major Sun Pharmaceutical Industries is recalling pre-filled syringes of a drug, used to treat infertility in women, in the US market due to a manufacturing issue, according to the US health regulator. In its latest Enforcement Report, the US Food and Drug Administration (USFDA) noted that the Mumbai-based drug major is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection.

The company is recalling the affected lot due to the presence of particulate matter, the USFDA said.

"A piece of glass was found in a prefilled syringe," it added.

The product was manufactured by Sun Pharma and distributed in the US market by New Jersey-based Ferring Pharmaceuticals Inc. The company initiated the countrywide (US) recall on April 19 this year, USFDA stated.

The New Jersey-based Sun Pharmaceutical Inc, a unit of the company, has already announced the recall of 16,450 vials of

Norepinephrine Bitartrate Injection for "failed impurities/degradation specifications".

As per the USFDA, the drugmaker is also voluntarily recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing.

Read also: Hetero, Sun Pharma recall products in US over manufacturing issues

The Indian pharmaceutical industry is the world's third-largest by volume and 14th-largest in terms of value. India exported pharmaceuticals worth Rs 1,75,040 crore in the financial year 2021-22, including bulk drugs/ drug intermediates.

The US is the world's largest market for pharmaceutical products.

Read also: USFDA halts Sun Pharma trials on dermatological drug Deuruxolitinib

Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates.

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Sun Pharma recalls pre-filled syringes of infertility drug in US over manufacturing issue

"A piece of glass was found in a prefilled syringe," USFDA said.

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