Incorrect Tablet Arrangement Leads to Oral Contraceptive Recall
Indicating for preventing pregnancy, a statement from the FDA said that loss of efficacy is possible if the user misses tablets.
Officials with Apotex Corp announced they are voluntarily recalling 4 lots of drospirenone and ethinyl estradiol tablets, USP to the user level, because they 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.
Indicating for preventing pregnancy, a statement from the FDA said that loss of efficacy is posible if the user misses tablets.
Drospirenone and ethinyl estradiol tablets (inner carton) consists of 28 film-coated, biconvex tablets in the following order: 21 yellow color tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), and 7 placebo white color tablets. The affected drospirenone and ethinyl estradiol tablets, USP lots can be identified by NDC numbers stated on the inner and outer cartons: NDC# 60505-4183-3 and contains 3 inner cartons (NDC# 60505-4183-1).
The affected Drospirenone and Ethinyl Estradiol Tablets were distributed Nationwide to wholesalers and distributors. Patients who have received impacted lots or have questions regarding this recall are being asked to contact their pharmacy and, the impacted packages can be returned to the pharmacy.
Customers who purchased the impacted product directly from Apotex can call GENCO at 1- 877-674-2082, 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 at www.fda.gov/medwatch/report.htm.