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Lupin Pharmaceuticals Inc. said the recall covers lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level.
These 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 in the US to wholesalers, clinics and retail pharmacies.
"As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy," the FDA said. "The reversing the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order."
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Lupin is notifying its distributors and customers by recall letter and is arranging for return of all recalled products.
Consumers who have the affected product should notify their physician and return the product to the pharmacy or place of purchase.
Consumers with questions can call Lupin at (800) 399-2561, 8 a.m. to 5 p.m., Monday through Friday.