Recall: Birth Control Pills Packaged Out of Sequence

Apotex Inc. is recalling four lots of drospirenone and ethinyl estradiol tablets, 3 mg/0.03 mg, because of incorrect tablet placement and/or empty blister pockets, according to the March 13, 2019, US Food and Drug Administration (FDA) Enforcement Report.

“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,” stated an Apotex press release dated March 4, 2019. “To date, no case has been reported for pregnancy and adverse event to Apotex.” 

The affected tablets were manufactured by Oman Pharmaceutical for Apotex Corp. and are packaged in an outer carton (NDC 60505-4183-3) that contains three inner cartons (NDC 60505-4183-1). Each inner carton contains one blister pack with 21 yellow active tablets and 7 white placebo tablets.  

The recalled cartons, which were distributed throughout the United States, are from lots 7DY008A, 7DY009A, 7DY010A, and 7DY011A (Exp. 8/20).

Apotex voluntarily initiated the recall March 1, 2019. The FDA designated it Class II on March 11, 2019, communicating use of the pills may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Drospirenone and ethinyl estradiol tablets are prescription hormonal contraceptives used to prevent pregnancy and treat premenstrual dysphoric disorder and acne. 

—Jolynn Tumolo