Drug product
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.
D-0992-2019
Product summary
- Firm
- Apotex Inc.
- Event
- Event 82288
- Status
- Completed
- Classification
- Class II
- Quantity
- 82,705 cartons
- Official record key
drug-enforcement:D-0992-2019
Official wording
Reason: Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Code information: Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.