Here are four things to know.
1. During production, pill packs were improperly flipped 180 degrees when placed into the packaging, reversing the pill packs’ weekly tablet orientation.
“The first four days of therapy would have had four nonhormonal placebo tablets as opposed to the active tablets,” the Food and Drug Administration said in a recall alert. “[O]ral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.”
2. The medication’s lot number and expiration date were also absent from the pill packs due to the packaging error.
3. Lupin recalled the affected lot — which was distributed to wholesalers, clinics and retail pharmacies nationwide — and is working with customers to arrange the return of all affected pill packs, according to the report.
4. The FDA has not received any reports of adverse event associated with the medication.
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