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.
Reported: March 13, 2019 Initiated: March 1, 2019 #D-0992-2019
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.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 82,705 cartons
- Distribution
- Nationwide in the USA.
- Location
- North York, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Apotex Inc.. Units affected: 82,705 cartons.
Why was this product recalled? ▼
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 13, 2019. Severity: Moderate. Recall number: D-0992-2019.
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