Apotex has issued a voluntary recall of four lots of its Drospirenone and Ethinyl Estradiol tablets, USP 3MG / 0.03MG, due to a US packaging error.

The lots are being recalled as they may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket.

Due to this packaging error, a patient may not take a dose due to a missing tablet or they may take a placebo instead of an active tablet, which may result in loss of efficacy due to variation in the dosage consumed.

Oman Pharmaceutical Products manufactured the affected product under the subcontract from Germany-based Helm.

Apotex stated: “Drospirenone and Ethinyl Estradiol Tablets, USP, are an estrogen/progestin COC indicated for use by women to prevent pregnancy.

“Drospirenone and ethinyl estradiol tablets (inner carton) consist of 28 film-coated, biconvex tablets in the following order: 21 yellow-colour tablets, each containing 3mg drospirenone (DRSP) and 0.03mg Ethinyl estradiol (EE), and seven placebo white-colour tablets.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
“Patients with affected lots have been urged to consult their healthcare provider.”

The company noted that it has not received any reports of adverse events to date.

Apotex has notified its affected wholesalers and distributors via mail. It is also arranging for the return of all the recalled products.

Customers can identify the affected lots through NDC numbers stated on the inner and outer cartons.

Patients with affected lots have been urged to consult their healthcare provider.