Sandoz recalls some Introvale birth control pills
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Novartis AG's unit Sandoz is voluntarily recalling 10 lots of its generic Introvale birth control pills after a consumer recently reported a packaging flaw.
Sandoz said in a post on its website on Tuesday that it decided on the recall after a consumer reported that white placebo tablets were mistakenly placed in the wrong row of a 13-row card.
"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," Sandoz said, noting it is not aware of any adverse events stemming from the flaw.
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The lot numbers involved in the recall are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the United States between January 2011 and May 2012, Sandoz said.
If a patient finds a white placebo tablet in any position other than the 13th and final row, for the 13th week, she should immediately start using a non-hormonal form of contraception, according to a notice sent out on Wednesday by the U.S. Food and Drug Administration.