Drug Safety Alerts

Drospirenone and Ethinyl Estradiol 3 mg/0.02 mg Consumer-Level Recall

07/24/2019

On July 24, 2019, the United States Food and Drug Administration issued a notice regarding a consumer-level recall of Drospirenone and Ethinyl Estradiol 3 mg/ 0.02mg tablets NDC # 59746-0763-43 manufactured by Jubilant Cadista Pharmaceuticals.

This recall was issued due to out-of-specification (OOS) dissolution results at the 3-month stability time point. As a result of the OOS dissolution results, product efficacy may be decreased due to incomplete absorption of the active ingredients. To date, Jubilant Cadista Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

This recall affects lot number 183222 exp. 11/30/2020. No other lots are affected by this recall. The affected lot went into distribution on May 9, 2019.

Please note: This recall was originally issued to the retail-level on July 10, 2019.

CVS Caremark^® Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact Jubilant Cadista at 1‑800-308-3985, Monday through Friday, 9:00 a.m. – 6:00 p.m (ET). You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.