Jubilant Cadista has issued a voluntary recall of one lot of birth control pills produced under contract by Cyndea Pharma in Spain because it failed dissolution tests.
The recall covers blister packs of combination drospirenone and ethinyl estradiol tablets, the FDA reported. The specific cause cited for the voluntary recall is out-of-specification dissolution results at the three-month mark.
Improper dissolution can lead to decreased efficacy, the agency said, because of incomplete absorption of the active ingredients.
The Maryland-based company said it hasn’t received any reports of adverse events related to the recall. The recall is for lot number 183222 with NDC number 59746-763-43 and an expiration date of November 2020.
The estrogen/progestin combined contraceptive is also used to treat symptoms of premenstrual dysphoric disorder and to treat acne for females at least 14 years old.