Janssen Pharmaceuticals has recalled three lots of birth control pills after it was discovered that the medication’s dispensers were printed without “appropriate” instructions, the FDA said.
One lot of Ortho-Novum 1/35 and two lots of Ortho-Novum 7/7/7 were recalled because the taking the pills without following the proper instructions could cause women to take them in the wrong order, according to a recall alert
It could also lead women to take an inactive “reminder” pill instead of an “active” pill which could cause unintended pregnancy or bleeding, officials said.
The pills must be taken in the correct order for them to be effective.
The FDA provided a list of the three affected lots.
Janssen Pharmaceuticals issued a statement on the recall and provided correct instructions on its web site.
“The Ortho-Novum product itself remains safe and effective for use with the appropriate dispenser instructions,” the statement said. “Women should continue to take the 21 ‘active’ pills for three weeks, followed by the one week of ‘reminder’ pills.”
The pills were were distributed in the U.S. wholesalers, distributors and pharmacies, and they have been notified by recall letter to return affected products, the FDA said.
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