Safety Alerts & Recalls

What does this mean?

Sandoz has determined that the probability of adverse health events from use of the recalled Estarylla is very low, as the packaging flaw is easily to see and the risk of pregnancy occurring after not taking one blue active tablet is low. That said, please check your supply of birth control pills and see if you have any packages of Estarylla with the lot number LF01213A. If you have packages from this lot number, please check to make sure the tablets are packaged correctly: Each blister card should contain three rows of 7 active blue tablets and one row of 7 green placebo tablets.

If you experience an adverse reaction or quality problem involving Estarylla, you should immediately contact your healthcare provider as well as Sandoz to report the problem. 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.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: www.fda.gov/medwatch

Sandoz Announces Voluntary Recall of One Lot of Estarylla

Sandoz is conducting a voluntary nationwide recall at the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US, following a customer report of a green placebo tablet present in a row of blue active tablets in one package.

The lot number, expiration date, and NDC code of the recalled lot is: LF01213A, expiration date 02/2014, NDC 00781-4058-15. Sandoz is not aware of any reports to date of adverse events related to the use of Estarylla from this lot.

Estarylla is an oral contraceptive indicated for the prevention of pregnancy. Estarylla contains the active ingredients (norgestimate and ethinyl estradiol). No other oral contraceptives or products containing norgestimate and ethinyl estradiol were involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2013-07-08
Last Updated: 2013-07-09

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