Sandoz is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets, following a customer report of a placebo tablet present in a row of active tablets on one pack. Estarylla is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. An internal medical assessment concludes 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 US market only. Estarylla is manufactured for Sandoz by a third party manufacturer.
See the Recall
See also Medical Law Perspectives, February 2012 Report: The New Oral Contraceptives: Stroke and Other Adverse Event Liability