Dr Reddy's Labs, Sun Pharma recall products in American market over manufacturing issues

Published On 2024-05-31 06:41 GMT | Update On 2024-05-31 06:42 GMT

New Delhi: Dr Reddy's Laboratories and Sun Pharma are recalling products in the American market following manufacturing concerns, as stated by the US Food and Drug Administration (USFDA).

The USFDA said that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication.

Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said.

The company initiated the Class III recall on May 1, 2024, according to PTI report.

In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases.

New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test".

The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated.

Read also: Cipla, Glenmark recall products from American market over manufacturing issues

As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

India is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

Read also: Dr Reddy's recalls six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg over sub potency

Medical Dialogues team had earlier reported that pharmaceutical companies Dr Reddy's Laboratories, Sun Pharma, and Aurobindo Pharma recalled products from the US market over manufacturing issues.

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

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.

Read also: Sun Pharma, Dr Reddy's Labs, Aurobindo recall products in US over manufacturing issues

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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Dr Reddy's Labs, Sun Pharma recall products in American market over manufacturing issues

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