Dr Reddy's Laboratories Limited has started recalling anti-seizure drug Divalproex extended release tablets from the US market owing to cGMP deviations noticed in certain batches of the product.
According to information posted on the US Food and Drug Administration(USFDA), the company initiated a voluntary recall of Divalproex 100-count and 500-count bottles, totaling 33,958 bottles on April 11, 2019 after finding out that the product was exposed to huimdity levels above 50 percent during packaging.
Categorised as class II recall, the noticed deviation presents 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, as per the US drug regulator. The company manufactured the bottles at its Bachupally facility in Hyderabad.
This is the second recall of the drug since it was launched in August 2013 in the US. First time it had recalled the drug in June 2015 for 'failed dissolution specifications, exceeding specification at the 9-hour time point," under the similar Class II recall.
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