Dr Reddy’s re­calls over 80k Ator­vas­tatin bot­tles from US

BioSpectrum (India) - - POLICY AND REGULATORY NEWS -

Dr Reddy’s Lab­o­ra­to­ries has ini­ti­ated the vol­un­tary re­call­ing of more than 80,000 bot­tles of its drug Ator­vas­tatin Cal­cium Tablets 10mg, 20mg and 40mg from the US mar­ket due to qual­ity con­cerns.

Ac­cord­ing to a no­ti­fi­ca­tion is­sued by the US Food and Drug Ad­min­is­tra­tion (USFDA), mul­ti­ple lots of Ator­vas­tatin 10 mg, 90 count and 500 count bot­tles; 20 mg, 90 count and 500 count bot­tles and 40 mg, 90 count bot­tles, are be­ing with­drawn from the mar­ket. Ator­vas­tatin is a drug that blocks the pro­duc­tion of choles­terol and re­duces its level in the blood. The prod­uct is be­ing re­called through three sep­a­rate let­ters to the drug reg­u­la­tor. The prod­uct was man­u­fac­tured at Dr Reddy’s Srikaku­lam plant in Andhra Pradesh.

Once the FDA com­pletes the haz­ard as­sess­ment, the En­force­ment Re­port en­try will be up­dated with the re­call clas­si­fi­ca­tion (Class I, II or III) in­di­cat­ing the haz­ard posed by the re­called prod­uct(s).

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