WASHINGTON (dpa-AFX) - Jubilant Cadista Pharmaceuticals has voluntarily recalled one lot of oral contraceptive tablets at the consumer level, citing potential decreased efficacy of the product.
The company has recalled one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg. The product was manufactured by Spain-based Cyndea Pharma under contract from Jubilant Cadista.
The oral contraceptive tablets are an estrogen and progestin combination, indicated for use by women to prevent pregnancy and also to treat symptoms of premenstrual dysphoric disorder or PMDD for women who choose to use an oral contraceptive for contraception.
The drug is also used to treat moderate acne for women of at least 14 years of age, and if the patient desires an oral contraceptive for birth control.
The affected lot was recalled due to out-of-specification or OOS dissolution results at the stability time point of three months. As a result of the OOS dissolution results, the product's efficacy may be decreased due to incomplete absorption of the active ingredients.
However, Jubilant Cadista said it has not received any reports of adverse events related to this recall, which is being conducted with the knowledge of the U.S. Food and Drug Administration.
The affected tablets have been identified as Lot number 183222, with NDC number 59746-763-43 and expiration date of 11/2020. They were distributed nationwide to wholesalers, distributors, and retailers.
The tablets are packaged into a carton containing three blister cards. Each blister card contains 28-film coated, biconvex tablets.
The tablets comprise 24 active pink-color round, unscored, film-coated tablets debossed with a '20' on one side, each containing Drospirenone and Ethinyl Estradiol, and 4 inert white-color round, unscored, film-coated tablets debossed with a 'PL'.
Jubilant Cadista is notifying its customers by a recall notification letter via email and is arranging for return of all recalled product. Patients who have used the affected lot of tablets have been urged by the company to consult their healthcare provider.
The company also advised wholesalers, distributors, and retailers to immediately examine their inventory for the affected lot.
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