Apotex announced a voluntary recall of 4 lots of Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg due to the possibility of defective blisters with incorrect tablet arrangements and/or empty blister pockets.
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 7 placebo white tablets.
The following lots have been recalled: 7DY008A, 7DY009A, 7DY010A, and 7DY011A. The outer carton displays NDC# 60505-4183-3 and contains 3 inner cartons (NDC# 60505-4183-1). The expiration date is listed as 8/2020.
The impacted products, manufactured by Oman Pharmaceutical Products Co., LLC, were distributed across the country to wholesalers and distributors. Recall notification letters were sent to affected parties and the recalled products may be returned to the place of purchase.
Loss of efficacy is possible if patients do not take the appropriate tablet or miss a tablet. At this time, Apotex has not received any reports of pregnancy or adverse events related to the recall.
For more information call (800) 706-5575 or visit Apotex.com.