RECALL ALERT: Birth control pills may have missing doses
The U.S. Food and Drug Administration is warning the public about a voluntary recall of a birth control pill, manufactured by Apotex Corporation.
Four lots of the pills, Drospirenone and Ethinyl Estradiol Tablets, may contain "defective blisters with incorrect tablet arrangements and/or an empty blister pocket."
According to the FDA, the affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.
The risk is that a patient using the birth control pills doesn't take a tablet due to a missing tablet, or takes a placebo table instead of an active pill.
The impacted lots of Drospirenone and Ethinyl Estradiol Tablets, USP 3MG/0.03MG.
The affected Drospirenone and Ethinyl Estradiol Tablets were distributed Nationwide to wholesalers and distributors.
Customers who purchased the impacted product directly from Apotex can call GENCO at 1- 877-674-2082 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for their return.
|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.