Drospirenone/Ethinyl Estradiol Tablets by Jubilant Cadista Recalled
Estradiol Tablets, USP, 3mg/0.02mg, 28x3 Blister Pack/Carton due to out-of-specification (OOS) dissolution results at the three-month stability time point. The OOS dissolution results indicate that the product may not be adequately effective due to low absorption of the active ingredients in the body.
Drospirenone/Ethinyl Estradiol Tablets are indicated to prevent pregnancy, to treat symptoms of premenstrual dysphoric disorder (PMDD), and to treat women at least 14 years of age who have moderate acne. The product is packaged in a carton containing three blister cards, each of which holds 24 active pink tablets and four white tablets. The affected lot number is 183222, with an expiration date of 11/2020.
For help with questions regarding the recall, consumers and healthcare providers should contact Jubilant Cadista at 1-800-308-3985. Jubilant Cadista advises patients to contact their healthcare provider if they have used tablets from the affected lot or have experienced adverse events that may be related to the product’s use. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
The full recall announcement can be viewed online at the FDA’s website.
Benecard Central Fill has not dispensed the recalled product.