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Ten Lots of Oral Contraceptive Introvale Recalled Due to Potential Packaging Error
FDA is alerting pharmacies and patients that manufacturer Sandoz has initiated a voluntary recall of 10 lots of Introvale®, a generic oral contraceptive distributed in the US, following a recent report of a packaging flaw. The recall was initiated due to a consumer report indicating 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. 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, FDA advises.
The following lots are recalled and were distributed only in the US between January 2011 and May 2012:
- LF00478C
- LF00479C
- LF00551C
- LF00552C
- LF00687C
- LF00688C
- LF00763C
- LF00764C
- LF00765C
- LF01261C
FDA advises that if a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), she should immediately begin using a non-hormonal form of contraception and contact her health care provider. Sandoz is not aware of any reports of related adverse events. FDA notes that any adverse events, side effects, or quality problems related to the use of these products can be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by calling 800/332-1088 or by completing the online form. More information is available in the FDA safety alert.
