FDA recall D-1148-2015

Actavis Inc · Class III · drug

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-06-04
Report date: 2015-07-01
Termination date: 2016-04-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2015