Pharmaceutical

Birth control pills recalled due to packaging flaw

birth control pill recall Birth control pills recalled due to packaging flawTen 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 qa.druginfo@sandoz.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.

Sources:
FDA