Reported Jul 1, 2015 · Terminated
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box,…
Actavis Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis Inc · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- 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 forWatson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880
- Manufactured byPatheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 KPPY, Exp 06/15 2 NBXD, NBXF, Exp 10/16 3 NBXG, Exp 09/15 4 NKZS, Exp 11/15 5 NMPT, NNXB, NNWG, Exp 01/16 6 NMPV, NVWN, NVWP, Exp 02/16 7 NMTP, NNXC, Exp 03/16 8 NMWC, NNXH, Exp 04/16 9 PFHT, PFHW, PFHX, Exp 06/16 10 PKHH, PKHN, PKHS, PKHT, PPGG, PPGH, PVSZ, Exp 08/16 11 PYDX, Exp 09/16. - Amount recalled
- 511,283 Boxes
Where it was sold
- Nationwide
- PR
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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