Oral Contraceptive Introvale Being Recalled


The pharmaceutical company Sandoz is voluntarily recalling 10 lots of its generic oral contraceptive Introvale in the United States due to a recent report of a packaging flaw. Sandoz is not aware of any related adverse events and the chance of the packaging flaw causing serious health consequences if very remote. However, the decision to recall the Introvale is a precautionary measure.

Lots distributed in the United States between January 2011 and May 2012 with lot numbers LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C are being recalled.
It was decided to recall the Introvale after a user reported the white placebo tablets were in the 9th row of the blister card rather than the 13th row where they belong. Patients taking the placebo pills several days in a row are at risk for unplanned pregnancy.

Sandoz cautions that if any patient finds a white placebo tablet in any position other than the 13th row they should immediately use a back-up non hormonal method of contraception such as condoms to prevent pregnancy.


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