Dr Reddy's recalls 80,000+ bottles of Atorvastatin from US
PTI|
Feb 08, 2018, 02.48 PM IST
HYDERABAD: Dr Reddy's Laboratories has initiated voluntary recall of over 80,000 bottles of its drug Atorvastatin Calcium Tablets 10mg, 20mg and 40mg from the US market 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 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10 mg, 90 count and 500 count bottles; 20 mg, 90 count and 500 count bottles and 40 mg, 90 count bottles, are being withdrawn from the market. 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 maker's Srikakulam plant in Andhra Pradesh.
The drug is being recalled under "not yet classified" category which, according to the FDA, means that a firm's action meets the definition of a recall, however, the FDA has not completed its assessment of the hazard posed by the recalled product(s) yet, and is considered a pending classification.
"Once 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)," said FDA.
Meanwhile, Glenmark Pharmaceuticals in a separate letter also initiated voluntary recall of 5,136 tunes of its Mometasone Furoate Cream, USP, 0.1 per cent 45gm from the US market due to violations of the CGMP (current good manufacturing practice) regulations set up by the USFDA.
Mometasone Furoate Cream is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.
Atorvastatin is a drug that blocks the production of cholesterol and reduces its level in the blood.
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10 mg, 90 count and 500 count bottles; 20 mg, 90 count and 500 count bottles and 40 mg, 90 count bottles, are being withdrawn from the market. 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 maker's Srikakulam plant in Andhra Pradesh.
The drug is being recalled under "not yet classified" category which, according to the FDA, means that a firm's action meets the definition of a recall, however, the FDA has not completed its assessment of the hazard posed by the recalled product(s) yet, and is considered a pending classification.
"Once 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)," said FDA.
Meanwhile, Glenmark Pharmaceuticals in a separate letter also initiated voluntary recall of 5,136 tunes of its Mometasone Furoate Cream, USP, 0.1 per cent 45gm from the US market due to violations of the CGMP (current good manufacturing practice) regulations set up by the USFDA.
Mometasone Furoate Cream is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.
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