Why it was recalled
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Product description
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.
Lot numbers, UPCs & expiration codes
Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020
Where it was sold
Nationwide in the USA.
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-0992-2019
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 1, 2019
- FDA report date
- Mar 13, 2019
- Quantity
- 82,705 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0992-2019, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Completed
- Country
- Canada
- Event ID
- 82288
- Address
- 150 Signet Drive
- Code information
- Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020
- Report date
- Mar 13, 2019
- Product type
- Drugs
- Recall number
- D-0992-2019
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 82,705 cartons
- Reason for recall
- Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 1, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 11, 2019