D-1148-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2015
- Initiation Date
- June 4, 2015
- Termination Date
- April 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 511,283 Boxes
Product Description
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 Pattern
Nationwide and Puerto Rico
Code Information
Lot #s: KPPY, Exp 06/15; NBXD, NBXF, Exp 10/16; NBXG, Exp 09/15; NKZS, Exp 11/15; NMPT, NNXB, NNWG, Exp 01/16; NMPV, NVWN, NVWP, Exp 02/16; NMTP, NNXC, Exp 03/16; NMWC, NNXH, Exp 04/16; PFHT, PFHW, PFHX, Exp 06/16; PKHH, PKHN, PKHS, PKHT, PPGG, PPGH, PVSZ, Exp 08/16; PYDX, Exp 09/16.