Estarylla (norgestimate and ethinyl estradiol): Recall - Report of Placebo Tablet Present in Row of Active Tablets

[Posted 07/05/2013]

AUDIENCE: Pharmacy, Patient

ISSUE: Sandoz notified the public it is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US, following a customer report of a placebo tablet present in a row of active tablets on one pack.

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.

BACKGROUND: Estarylla is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

RECOMMENDATION: The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/05/2013 - Press Release - Sandoz US]