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Dr. Reddy’s Laboratories is recalling more than 4,000 bottles of a generic drug in the U.S. due to a packaging error.
The Hyderabad-based drug major is recalling 4,320 bottles of Tacrolimus Capsules which are used to prevent the body from rejecting a transplanted organ.
New Jersey-based Dr. Reddy’s Laboratories Inc, a unit of the company, is recalling the affected lot due to “Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules,” U.S. FDA said in its latest Enforcement Report.
The affected lot was produced at the company’s Bachupally-based manufacturing plant and marketed in the U.S. by its American arm.
Dr. Reddy’s initiated the Class II nationwide recall on February 8 this year.
As per U.S. FDA, 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.
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