Drugmaker to Voluntarily Recall Estarylla Oral Contraceptive

Sandoz, the manufacturer of Estarylla, has announced a voluntary recall of one lot of the drug. Estarylla, a combination of norgestimate and ethinyl estradiol, is a birth control pill. This combination of two female hormones—estrogen and progestin—prevents pregnancy by preventing ovulation. Estarylla is dispensed in packages of 28 pills, with days marked off for a 28-day menstrual cycle. There are 21 blue pills that contain the active hormone ingredients and 7 green pills containing inactive ingredients. The pills with inactive ingredients are called “placebos” or sugar pills.

The reason for the recall is that a user reported finding a placebo tablet in a row of active pills, which could affect the regulation of the hormones. However, the patient did not suffer any adverse effects, and after a lengthy internal investigation, Sandoz concluded that the likelihood of adverse effects is extremely low because the packaging flaw is detected easily with the coloration of the tablets.

Sandoz also concluded that the risk of pregnancy is minimal from skipping one blue active pill. Oral contraceptives have a 99% effectiveness rate when taken as prescribed, making them the preferred form of birth control in the United States. Missing one or more of the active ingredient pills lowers the effectiveness rate; however, skipping the placebos has no effect.

The FDA approved Estarylla for use as an oral contraceptive on January 30, 2013. The lot affected by the recall is number LF01213A with a NDC code of 00781-4058-15 and an expiration date of 2/14. The NDC code is known as the “National Drug Code” and serves as the unique identifier for a specific drug. This Estarylla lot was supplied in boxes containing three blister cards of the 28-day packets and was only distributed in the United States to retailers.

Sandoz, working with the FDA, has set up a toll-free telephone line for any patients that experience any adverse reactions to the drug. The Sandoz Drug Information Direct Line is open 24 hours a day, seven days a week at 800-525-2492. Additionally, reports can be made via email at qa.druginfo@sandoz.com. Users should also contact their health care provider with any quality concerns about Estarylla.

References:
http://www.fda.gov/drugs/informationondrugs/ucm142438.htm
http://www.medschat.com/Drugs/Estarylla/
http://www.fda.gov/Safety/Recalls/ucm359613.htm