Ten lots of the generic birth control pill Introvale made by Sandoz are being recalled because of a packaging flaw that if undetected could result in unintended pregnancy.
The recall was initiated after a consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, with each row representing one week. While the white placebo pills can be clearly distinguished from the peach-colored active tablets, if a patient mistakenly takes the pills out of order she is at risk of unintended pregnancy.
The recall involves the following lots of Introvale: LF00478C, LF00479C, LF00551C, LF00552C
Last fall, birth control pills made by Qualitest Pharmaceuticals were recalled due to a packaging error that had the potential for causing unintended pregnancy. That recall affected 1.4 million packages of Cyclafem 7/7/7; Cyclafem 1/35; Emoquette, Glidess FE 1.5/30; Glidess FE 1/20; Orsythia; Previfem; and Tri-Preifem.
In the event that a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), she should immediately begin using a non-hormonal form of contraception. She should also immediately contact her health care professional as well as Sandoz to report the finding via the Sandoz Drug Information Direct Line at 800-525-2492, 24 hours a day, seven days a week, or via email at email@example.com.
Any side effects with this or any drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.