RECALL: Introvale Packaging Error Recall

Sandoz issued a voluntary recall of Introvale (levonorgestrel 0.15mg, ethinyl estradiol 30mcg tablets), a progestin-estrogen combination extended-cycle oral contraceptive.

This recall is following a recent consumer report in which the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct 13^th and final row (labeled “Week 13”). While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012. 

If patients find a white placebo tablet in any position other than the 13^th and final row (labeled “Week 13”), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm307103.htm.