Sandoz recently announced a recall of ten lots of the Introvale oral contraceptive. The recall is being implemented because of a packaging error, causing serious adverse health consequences including unintended pregnancy.
This product is used for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Each three-month blister card contains 84 peach-colored active tablets and 7 white placebo tablets. In the packs with the error, the placebo tablets are placed in the 9th week slot instead of the correct 13th week slot.
These tablets were manufactured and packaged by Sandoz and are distributed in the United States. These lots were distributed only in the United States from January 2011 through May 2012.
The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C.
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. Sandoz recommends that the person call their health service provider immediately, and call or email the Sandoz Drug Information Direct Line at 800-525-2492 or firstname.lastname@example.org to report the error.
If you have experienced an unintended pregnancy due to packaging error or incorrectly dosed birth control, a defective products attorney may be able to help you pursue the compensation you deserve. For more information, call 1-888-BURNETTI.