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Dr Reddy's recalls 8,000 bottles of generic drug in US over packaging error

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

Dr Reddy’s Laboratories

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

Press Trust of India New Delhi

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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.
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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Jan 07 2024 | 10:44 AM IST

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