FDA announces recall of birth control pills

www.FDA.gov
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An error with packaging is prompting a nationwide recall of birth control pills.

The Food and Drug Administration (FDA) announced that Apotex Corporation is recalling four lots of Drospirenone and Ethinyl Estradiol.

The company said packaging may contain defective blisters, missing tablets and tablets that are arranged incorrectly.

As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage taken.

No pregnancy has been reported, according to Apotex.

Users with questions regarding this recall are urged to contact their pharmacy and healthcare provider for medical advice and return the impacted packages to their pharmacist.

Drospirenone and Ethinyl Estradiol is an estrogen/progestin combination oral contraceptive indicated for the prevention of pregnancy. The tablets in the inner carton are arranged as 21 active yellow tablets followed by seven white placebo tablets.

The following lots have been recalled: 7DY008A, 7DY009A, 7DY010A, and 7DY011A. The outer carton displays NDC# 60505-4183-3 and contains three inner cartons (NDC# 60505-4183-1). The expiration date is listed as 8/2020.

Consumers with questions regarding this recall can contact Apotex corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com.