Novartis’ Sandoz recalls Introvale oral contraceptives in US

Switzerland-based pharmaceutical company Novartis’ subsidiary Sandoz is conducting a voluntary recall of its generic oral contraceptive pills Introvale in the US, following a report of a packaging error in nearly 10 lots, distributed between January and May 2012.

According to the company, the recall comes after it was reported that white placebo tablets were mistakenly placed in the wrong row of a 13-row card.

Introvale, a three-month birth-control regimen, contains 84 peach coloured active pills and seven inactive pills of week 13 feature white colour.

The US Food and Drug Administration (FDA) said the recall was prompted by a consumer report of the inactive pills being located in the row labelled week nine.

"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 added.

Lot numbers recalled include LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C, the company said.

Sandoz was said to be unaware of any unintended pregnancies and other problems from the packaging error, though it recalled the pills as a precautionary measure to minimise the potential of patients being impacted.

The agency said that if any 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 or visit a doctor, reported Reuters.