Apotex Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged a…

Recall date

March 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0992-2019

FDA classification

Class II

Brand / firm

Apotex Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.