Medication Monitor



Generic Name (Trade Name—Company)
Notes
May 31, 2017

Norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg and ferrous fumarate 75 mg

(Mibelas 24 Fe—Lupin Pharmaceuticals)
Tablets in one lot are out of sequence and missing expiry/lot info

Lupin Pharmaceuticals is voluntarily recalling lot L600518 (expiration 05/18) of norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg tablets.

A confirmed market complaint indicated a packaging error, in which the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first 4 days of therapy would have had four nonhormonal placebo tablets instead of active tablets—which may place the user at risk for contraceptive failure and unintended pregnancy.

To date there have been no reports of such adverse events.

The products are packaged in blister packs containing 28 tablets: 24 white to off-white tablets of active ingredients debossed with “LU” on one side and “N81” on the other; and 4 tablets of inert ingredients debossed with “LU” on one side and “M22” on the other side. This product was distributed nationwide to wholesalers, clinics, and retail pharmacies.

Lupin is notifying its distributors and customers by recall letter and is arranging for return of all recalled products.