Dr Reddy's Laboratories is recalling over 8,000 bottles of a generic medication used to prevent rejection of a transplanted organ from the U.S. market due to a packaging error, according to the U.S. Food & Drug Administration.
The Hyderabad-based drug major is recalling 8,280 bottles of Tacrolimus capsules from the U.S. market for 'presence of foreign tablets/capsules' in the affected lot.
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One 0.5 mg Tacrolimus capsule was found in a bottle of 1 mg Tacrolimus capsules, the U.S. FDA 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 (U.S.) Class II recall on Dec. 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 Feb. 8, 2023.
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