The FDA is recalling some birth control pills over incorrect tablet arrangements and/or an empty blister pocket.
Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP.
As a result of the 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.
The affected Drospirenone and Ethinyl Estradiol Tablets, USP lots include the following and can be identified by NDC numbers stated on the inner and outer cartons:
|NDC number on outer carton||NDC Number on inner carton||Lot Number||Expiration Date||Strength||Configuration/Count|
|60505-4183-3||60505-4183-1||7DY008A||8/2020||3MG / 0.03MG||Outer Carton: Contains three inner Cartons |
Inner Carton: Contains 1 blister with 21 active yellow color tablets and 7 placebo white color tablets.
The affected Drospirenone and Ethinyl Estradiol Tablets were distributed nationwide to wholesalers and distributors.
Consumers with questions regarding this recall can contact Apotex corp. by phone-number at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email them at UScustomerservice@Apotex.com .