Why it was recalled
Failed dissolution specifications : failed results at the 3-month stability time point.
Product description
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
Lot numbers, UPCs & expiration codes
Lot #: 183222, Exp 11/2020
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1837-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 9, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- 11,412 cartons/34,236 blister cards/28 tablets each card
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1837-2019, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 83408
- Address
- 207 Kiley Dr
- Code information
- Lot #: 183222, Exp 11/2020
- Postal code
- 21801-2249
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1837-2019
- Classification
- Class I
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 11,412 cartons/34,236 blister cards/28 tablets each card
- Termination date
- May 7, 2021
- Reason for recall
- Failed dissolution specifications : failed results at the 3-month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 9, 2019
- Initial firm notification
- Center classification date
- Aug 19, 2019