HYDERABAD: Pharma firm Dr Reddy’s Laboratories Ltd (DRL) has recalled Divalproex extended release tablets used as anti-seizure drugs, from the US market, citing CGMP deviations in certain batches of the product.
The recall is categorised as Class-II, where the noticed deviations include use of or exposure to a violative product probably causing temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, as per the US Food and Drug Administration (FDA).
This is the second recall since the launch of the product in August 2013. DRL first recalled the drug in June 2015. It was also a Class-II recall for failed dissolution specifications, “exceeding specification at the 9-hour time point”.
According to the US FDA, DRL initiated a voluntary recall of Divalproex 100-count and 500-count bottles, totalling 33,958 bottles on April 11 after finding that the product was exposed to humidity levels above 50 per cent while packaging. The product was manufactured at DRL’s Bachupally facility, Hyderabad. The financial impact of the recall couldn’t be immediately ascertained.
It may be noted that recently, DRL said it had received an Establishment Inspection Report from FDA on its Formulations Manufacturing Plant 3 at Bachupally. In February, it got a breather of sorts from FDA, which closed a three-year-old inspection of its onco-injectables plant in Duvvada, which was under lens since November 2015. It was re-inspected in March 2017 and later in October 2018 with eight observations including five repeat observations, of which four were from the warning letter. DRL responded with a corrective plan, following which the FDA finally closed the inspection.
Precedents