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Lupin Recalls Oral Contraceptive From US Market

According to the US drug watchdog - USFDA - as many as 24,652 tablets are being recalled.
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Lupin Recalls Oral Contraceptive From US Market
Hyderabad: Pharma major Lupin, through its USA subsidiary Lupin Pharmaceuticals, Inc has initiated voluntary recall of tablets Mibelas 24 Fe from the USA market as they are "out of sequence." According to a notification issued by the US Food and Drug Administration (USFDA), as many as 24,652 tablets are being recalled under 'class-I' classification.

According to the USFDA, class-I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Tablet Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) is an oral contraceptive indicated for the prevention of pregnancy in women, who elect to use oral contraceptives. These products are packaged in blister packs containing 28 tablets.

"Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package," the FDA notification said as reasons for recall.

The product was manufactured by Lupin Limited, India and distributed by Lupin Pharmaceuticals Inc in the US.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

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