Oral Contraceptives Recalled

A labelling error has prompted Xiromed LLC to issue a voluntary recall for Altavera levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg and 0.03 mg (NDC 70700-116-85),  according to the October 17, 2018, US Food and Drug Administration (FDA) Enforcement Report. Xiromed is concerned a mistake concerning the product’s generic name on packaging may cause confusion.

The recall is for 40,064 units, which each contain three tablet dispensers with 28 tablets. The recalled units are from lots LF11838A (Exp. 5/20), and LF12107A and LF12106A (Exp. 6/20). The products, manufactured by Xiromed by Laboratorios Leon Farma SA, were distributed throughout the United States.

The recall was issued by Xiromed September 18, 2018. On October 11, 2018, the FDA designated it Class III, suggesting use of the affected product is not likely to cause harm.

Altavera is a prescription oral contraceptive.  

—Jolynn Tumolo

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