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Recall of Oral Contraceptive Introvale® Following Report of Packaging Flaw


A voluntary recall of 10 lots of Sandoz generic oral contraceptive Introvale® in the US has been made following a recent report of a packaging flaw. The probability of this packaging flaw causing serious adverse health consequences is remote and Sandoz is not aware of any reports of related adverse events. The recall is a precautionary measure to minimize any potential of patients being impacted.

 

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.

 

The recall was decided after a consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled "Week 9") of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled "Week 13"). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week (see figure below). 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.

 

In the 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. They should also immediately contact their healthcare professional as well as Sandoz to report the finding.

 

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