FAQs – Consumer/Patients ONLY
Jubilant Cadista Pharmaceuticals Inc. Recall Initiated 07/09/2019
|
Drospirenone and Ethinyl Estradiol Tablets |
|
Product Name |
NDC Number |
Lot Number |
Expiration Date |
|
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton |
59746-763-43 |
183222 |
11/2020 |
1. What is the subject of the Voluntary Recall?
Answer: Drospirenone and Ethinyl Estradiol Tablets distributed by for Jubilant Cadista Pharmaceuticals Inc.
2. Why is this product being recalled?
Answer: The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point.
3. Who is the manufacture of this product? Answer: The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain under contract from Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Drive Salisbury, Maryland 21801.
4. How did this happen?
Answer: 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.
5. What is the risk to patients?
Answer: Potential for decreased efficacy for the indication the product is being taken. The product is indicated for use by women to: 1) prevent pregnancy, 2) treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception, and 3) treat moderate acne for women at least 14 years old, only if the patient desires an oral contraceptive for birth control.
6. What is the depth of the recall or the level in the distribution chain to which the recall extends?
Answer: - Consumer/Patient Level - Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, lot 183222 was distributed Nationwide to wholesalers, distributors, and retailers.
7. How do I receive credit for product that I’ve already returned?
Answer: Instructions to request for refund/credit of recalled product will be included in the return kit.
8. If I do not have any more of that product. Do I still get credit?
Answer: No. Credit will only be issued for product that it’s been returned.
9. How do I find out more information about this recall?
Answer: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts or email FDA at druginfo @FDA.hhs.gov or by phone 855-543-3784