A row of the oral contraceptive tablets contained a placebo
July 8, 2013Sandoz is recalling one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US.
A customer reported a placebo tablet present in a row of oral contraceptive tablets on one pack. Sandoz says it is not aware of any reports to date of related adverse events.
The company contends that the probability of adverse health events is minimal, as the packaging flaw is easily visible and the risk of pregnancy occurring after non-administration of one blue tablet is low.
The lot number, expiration date, and NDC code of the recalled lot is:
LF01213A, expiration date 02/2014, NDC 00781-4058-15.
It is supplied in cartons containing 3 blister cards of 28 tablets each. This lot was distributed to the U.S. market only.
The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week, or reports can be made via email at qa.druginfo@sandoz.com.