Dr Reddy's Labs recalls over 8000 bottles of generic medication in US over packaging error

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-01-08 06:23 GMT | Update On 2024-03-26 12:12 GMT

New Delhi: Dr Reddy's Laboratories is recalling over 8,000 bottles of a generic medication used to prevent rejection of a transplanted organ from the US market due to a packaging error, according to the US Food & Drug Administration. The Hyderabad-based drug major is recalling 8,280 bottles of Tacrolimus capsules from the US market for "presence of foreign tablets/capsules" in the...

New Delhi: Dr Reddy's Laboratories is recalling over 8,000 bottles of a generic medication used to prevent rejection of a transplanted organ from the US market due to a packaging error, according to the US Food & Drug Administration. The Hyderabad-based drug major is recalling 8,280 bottles of Tacrolimus capsules from the US market for "presence of foreign tablets/capsules" in the affected lot.

One 0.5 mg Tacrolimus capsule was found in a bottle of 1 mg Tacrolimus capsules, the USFDA stated in its latest Enforcement Report.

The affected lot was produced at Dr Reddy's Bachupally-based plant near Hyderabad.

New Jersey-based Dr Reddy's Laboratories, Inc has initiated the nationwide (US) Class II recall on December 15, 2023.

Read also: Dr Reddy's Labs acquires entire MenoLabs supplements portfolio

As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Dr Reddy's had recalled 4,000 bottles of the same drug in March last year as well. The company had initiated the recall on February 8, 2023.

Read also: Dr Reddy's Labs recalls 4320 bottles of Tacrolimus Capsules in US over packaging error

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offer 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. Dr Reddy's major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

Original news source: https://www.ptinews.com/story/business/dr-reddy-s-recalls-over-8-000-bottles-of-generic-drug-in-us-due-to-packaging-error/1020638

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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 recalls over 8000 bottles of generic medication in US over packaging error

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