Some packages of the birth control pill Introvale were filled improperly, prompting a recall of 10 lots the drug, so that women are not impacted.
The blister packs holding the pills are usually made with rows of pills for each of 13 weeks. In the problematic lots, the placebo normally located in the the 13th row of blister packs, was also put in the ninth row, according to the announcement released by the U.S. Food and Drug Administration.
Sandoz, a Princeton-based generic branch of Novartis AG, produced the pills.
The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the United States between January 2011 and May 2012.
The FDA statement said that a consumer noticed the problem and reported it to authorities.
Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week.
The company said there was not a safety concern, but it could not rule out unintended pregnancy if the wrong pills are taken over several days, the FDA said.
The FDA said that in the unlikely event that a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and talk to their doctor.
To report the problem to the company, the Sandoz drug information direct line is 800-525-2492 (24 hours/day, seven days a week) or via email at firstname.lastname@example.org.
The FDA announcement has a photo of the blister pack.