A confirmed market complaint led to the recall, the FDA says, and claims the pills are labeled in reverse placing the four non-hormonal placeboes within the first four days of therapy, as opposed to the active pills.
The recall continues:
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 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. For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death. To date, there have been no reports of such adverse events.
The recall is for Lot No. L600518.
Consumers who have the affected product should notify their physician and return the product to the pharmacy or place of purchase.
Consumers with questions regarding this recall can contact Lupin by phone 1-800-399-2561, 8:00 a.m. to 5:00 p.m. EST, Monday through Friday.