Product: 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
Reason for recall: Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Recall initiated: 20150604
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated