Sandoz is recalling 10 lots of its generic oral contraceptive Introvale in the US, because of a packaging flaw.
The possibility that the packaging flaw will cause serious adverse health consequences are remote, and there are no reports to date of any adverse event. The recall is being made as a precautionary measure to minimize any potential of patients being impacted.
The lots were distributed only in the United States and were distributed between January 2011 and May 2012.
The recall was decided after receiving a consumer report 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 unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.