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Dr Reddy's recalls 80k bottles of Atorvastatin from US over quality issue

The product is being recalled through three separate letters to the drug regulator

Press Trust of India  |  Hyderabad 

Dr Reddy's

Dr Reddys Laboratories has initiated a voluntary recall of over 80,000 bottles of its drug 10mg, 20mg and 40mg from the due to quality concerns.

Atorvastatin is a drug that blocks the production of cholesterol and reduces its level in the blood.

According to a notification issued by the (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10 mg, 90 count and 500 count bottles; 20 mg, 90 count and 500 count bottles and 40 mg, 90 count bottles, are being withdrawn from the market. Dr Reddy's officials were not immediately available for comment.

The product is being recalled through three separate letters to the drug regulator.

According to the USFDA, the reason for the recall was, "Failed Impurities/Degradations specifications; out-of-specification results observed for Total Degradation Impurities during stability."

The product was manufactured at the drug makers Srikakulam plant in Andhra Pradesh.

The drug is being recalled under "not yet classified" category which, according to the FDA, means that a firms action meets the definition of a recall, however, the has not completed its assessment of the hazard posed by the recalled product(s) yet, and is considered a pending classification.

"Once 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)," said

Meanwhile, in a separate letter also initiated a voluntary recall of 5,136 tunes of its Mometasone Furoate Cream, USP, 0.1 per cent 45gm from the due to violations of the CGMP (current good manufacturing practice) regulations set up by the

Mometasone Furoate Cream is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.

First Published: Thu, February 08 2018. 16:10 IST
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