Ten lots of the generic oral contraceptive Introvale (Sandoz) have been recalled after reports that white placebo pills were located in the wrong row of the three-month blister cards.
Risk for serious adverse health consequences as a result of the packaging flaw is low, but the recall is being undertaken as a precautionary measure, the FDA said in a press release.
The affected lots were distributed in the United States between January 2011 and May 2012 and are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C.
Sandoz voluntarily issued the recall after a consumer reported the white placebo pills were mistakenly packaged in the 9th row, labeled “Week 9,” in the 13-row blister card rather than the correct 13th and final row.
The affected products contain 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week.
Although the white placebo tablets can easily be distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong pill over several days cannot be excluded. Any patient who finds a placebo pill in any position other than the 13th and final row of a three-month Introvale blister package should immediately begin using a non-hormonal form of contraception and contact their health-care provider.
Any such occurrence should be reported via the Sandoz Drug Information Direct Line at 800-525-2492, which is available 24 hours/day, seven days a week, or via email at firstname.lastname@example.org.