Sandoz recalls Introvale due to packaging flaw
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.