FDA-Drug2019-03-13Class II
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.
Apotex Inc.
Hazard
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Sold states
Nationwide in the USA.
Affected count
82,705 cartons
Manufactured in
150 Signet Drive, N/A, North York, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0992-2019Don't want to check this manually?
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