Hyderabad-based pharma major Dr Reddy's Laboratories is recalling over 8,000 bottles of a generic drug, used to prevent rejection of a transplanted organ, from the US market.
According to US Food & Drug Administration (USFDA), the medicines are being recalled because of a packaging error.
News agency PTI reported that 8,280 bottles of Tacrolimus capsules are being recalled from the US market for "presence of foreign tablets/capsules" in the affected lot. The recalled lot was produced at Dr Reddy's plant in Bachupally, near Hyderabad.
One 0.5 mg Tacrolimus capsule was found in a bottle of 1 mg Tacrolimus capsules, the latest USFDA Enforcement Report said.
New Jersey-based Dr Reddy's Laboratories, Inc. initiated the nationwide (US) Class II recall on December 15.
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.
—With PTI inputs
