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Packaging Flaw Prompts Contraceptive Recall
Placebo Tablets Misplaced in Introvale Blister Card
By News Staff
If the pills are taken in the wrong order, the risk of unintended pregnancy "cannot be excluded," said the FDA alert.
The lot numbers involved in the recall -- LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C -- were distributed in the United States between January 2011 and May 2012.
According to a June 5 Sandoz release, the probability of the packaging flaw causing serious adverse health consequences is remote, and the company is not aware of any reports of related adverse events.
The FDA recommends that any patient taking Introvale who finds one of the white placebo tablets in any row of the blister pack other than the 13th row should immediately begin using a nonhormonal form of contraception and contact her health care professional. Adverse events that may be related to the use of these products can be reported to MedWatch, the FDA's safety information and adverse event reporting program.