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
Advertisement

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.

Advertisement
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.
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.

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.

Read also: Sun Pharma gets CDSCO panel nod to study COPD drug combination

Tags:    
Article Source : with inputs

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News