August 09, 2019
Jubilant Cadista Pharmaceuticals Inc. is recalling a single lot of drospirenone and ethinyl estradiol tablets, 3 mg/0.02 mg, because samples failed to meet dissolution specifications during routine 3-month stability testing, according to the August 7, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 34,236 blister cards of 28 pills each (NDC 59746-763-43), packaged in 11,412 cartons, from lot 183222 (Exp. 11/20). The tablets were manufactured by Cyndea Pharma and distributed by Jubilant Cadista Pharmaceuticals to three wholesalers, six distributors, and one retailer in Florida, Louisiana, Mississippi, Ohio, New Jersey, New York, and North Dakota. Distributors and wholesalers may have further distributed the product, the FDA pointed out.
Jubilant Cadista Pharmaceuticals voluntarily initiated the recall July 9, 2019. At press time, the FDA had not yet issued a recall classification.
Drospirenone and ethinyl estradiol tablets are available with a prescription for pregnancy prevention or to treat premenstrual dysphoric disorder and acne.