Apotex has issued voluntary recall of Drospirenone and Ethinyl Estradiol Tablets, USP in the US over packaging error.
Image: Blister with no placebo tablets. Photo: courtesy of CNW Group / Apotex Corp.
Apotex is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP 28×3 blister pack/carton due to chances of missing or incorrect tablet arrangement.
The four recalled lots are expected to include defective blisters with incorrect tablet arrangements or an empty blister pocket. Oman Pharmaceutical Products produced the affected product as part of the subcontract from Germany’s Helm
Loss of efficacy is possible due to variation in the dosage, which may affect the health of patient. Apotex said no case has been reported for pregnancy and adverse event with the product to date.
Drospirenone and Ethinyl Estradiol Tablets, USP are an estrogen/progestin COC suggested for use by women to prevent pregnancy.
Drospirenone and ethinyl estradiol tablets (inner carton) include 28 film-coated and biconvex tablets in the following order, including 21 yellow color tablets. Each tablet contains 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), and seven placebo white color tablets.
The affected Drospirenone and Ethinyl Estradiol Tablets have been distributed to wholesalers and distributors across the nation.
Apotex also said that it has informed its affected wholesalers and distributors via mail by posting a recall notification letter and is arranging for return of all recalled product.
Patients or users holding the affected lots of Drospirenone and Ethinyl Estradiol Tablets, USP need to consult with their healthcare provider to avoid further issues.
Wholesalers, distributors and retailers return the impacted product to place of purchase, and others with an existing inventory of the product should quarantine the recalled lots immediately, said Apotex.
Consumers must contact their physician or healthcare provider, if they have experienced any problems that may be related to taking or using the affected product.
Adverse reactions or quality problems experienced with the use of product has to be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or fax.