(WFLA) – A voluntary recall has been issued for birth control pill packets because the pills could be arranged incorrectly or a pill could be missing from the packet.
Drospirenone and Ethinyl Estradiol Tablets were distributed nationwide to wholesalers and distributors.
The following information was released by the FDA:
The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC.
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 consumed. To date, no case has been reported for pregnancy and adverse event to Apotex.
Patients who have received impacted lots of Drospirenone and Ethinyl Estradiol Tablets, USP 3MG/0.03MG. or have questions regarding this recall should contact their pharmacy. Individuals should not interrupt their therapy, use a non-hormonal method of birth control, contact their health care provider for medical advice and may return the impacted packages to their pharmacist.
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 .
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.