DRUG RECALL - Estarylla Tablets used for Contraception
July 3, 2013, Sandoz issued a voluntary recall of Estarylla tablets (norgestimate and ethinyl estradiol). The recall has been issued due to a consumer complaint of a pack containing a placebo tablet present in a row of active tablets. The recall only affects one lot: LF01213A with an expiry date of 02/2014.
Estarylla is an oral contraceptive which is used in the prevention of pregnancy in women.
There have not been any adverse events related to this recall; however, there is a risk of pregnancy if the placebo pills are taken incorrectly. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
In the event that consumers experience problems while using this product, they should immediately contact their healthcare professional and report the issue to Sandoz. Sandoz can be contacted on their Drug Information Direct Line: 800-525-2492, available 24 hours a day, seven days a week, or via email at firstname.lastname@example.org.
Members using mail order should be aware that Benecard Central Fill did not dispense any of the affected lots.
Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787