Pharma major Lupin, through its US subsidiary Lupin Pharmaceuticals Inc., has initiated voluntary recall of tablets Mibelas 24 Fe from the US 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.
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 Ltd and distributed by Lupin Pharmaceuticals Inc in the US.