Times of India
June 19, 2017
City-based pharma giant Dr. Reddy’s Laboratories (DRL) has voluntarily recalled 13,221 cartons of Zenatane capsules, which is used to treat severe cystic acne, from the U.S. market.
Citing the reason for the recall, the company said the drug failed “dissolution specifications out of specification results observed for low dissolution.” The drug was being manufactured by Cipla Limited’s unit at Kurkumbh for DRL. The recall falls under ‘Class II’, which is defined by the U.S. Food and Drug Administration (USFDA) as 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. According to the information available on the USFDA site, the recall was initiated on March 22 and it is still ongoing.
DRL has informed the bourses that its API manufacturing facility at Miryalaguda has been cleared by the USFDA. “This is in reference to our intimation dated February 21, 2017, with regard to the audit of our API manufacturing plant at Miryalaguda, by the USFDA, wherein we were issued a Form 483 with three observations. In this regard, we would now like to inform you that we have received an Establishment Inspection Report (EIR) from the USFDA as closure of audit for the above referred facility,” the company added. The USFDA issues an EIR upon completion of an inspection. The EIR consists of the details of inspectional findings.
Original headline: Dr Reddy’s recalls Zenatane capsules from US market
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