Actavis Inc recalls Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box,…

Recall date

June 4, 2015

Source

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

Recall number

D-1148-2015

FDA classification

Class III

Brand / firm

Actavis Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28