Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP

PUBLISHED: Mar 5, 2019
Relevant to: All Healthcare Organizations

Apotex Corp., is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

The affected Drospirenone and Ethinyl Estradiol Tablets, USP lot numbers are listed in the recall notice.

As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed. To date, no case has been reported for pregnancy and adverse event to Apotex.

The affected Drospirenone and Ethinyl Estradiol Tablets were distributed Nationwide to wholesalers and distributors.

Apotex Corp. has notified its affected wholesalers and distributors via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Patients / users that have the affected lots of Drospirenone and Ethinyl Estradiol Tablets, USP which are being recalled should consult with their healthcare provider.

Wholesalers, Distributors and Retailers return the impacted product to place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. 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.

Consumers with questions regarding this recall can contact Apotex corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

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