Pharmaceutical

Estarylla birth control pills recalled due to packaging flaw

birth control pill recall Estarylla birth control pills recalled due to packaging flawOne lot of Estarylla birth control pills made by Sandoz is being recalled because a customer found an inactive tablet in a row of active tablets in one pack. The pill packs include blue tablets, or active pills, that contain a combination of the hormones norgestimate and ethinyl estradiol that work to stop ovulation and thus prevent pregnancy. The green pills, sometimes called placebos or sugar pills, contain only inactive ingredients.

Sandoz is not aware of any adverse events associated with the recall. The company conducted an internal medical assessment and concluded that the likelihood of adverse health effects 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 recall affects Estarylla lot number LF01213A, with the expiration date of 02/2014, and NDC code of 00781-4058-15. It is supplied in cartons containing three 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.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care professional as well as Sandoz to report the finding. 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.

Side effects associated with the recalled product should also be reported to the Food and Drug Administration (FDA) Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA