D-0992-2019 Class II
FDA drug recall D-0992-2019 was initiated by Apotex Inc. on March 1, 2019 and is designated Class II. Reason for recall: Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. Affected quantity: 82,705 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2019
- Initiation Date
- March 1, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82,705 cartons
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.
Reason for Recall
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Distribution Pattern
Nationwide in the USA.
Code Information
Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020