Recalls / Class III

Class IIID-1148-2015

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

Affected lot / code info

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.

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.

Recalling firm

Firm

Actavis Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

400 Interpace Pkwy, Parsippany, New Jersey 07054-1120

Distribution

Quantity

511,283 Boxes

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2015-06-04

FDA classified

2015-06-24

Posted by FDA

2015-07-01

Terminated

2016-04-12

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1148-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.