FDA Drug recall D-1148-2015
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…
- FDA Drug
- Class III
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class III recall of 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… by Actavis, citing labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1148-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-06-04 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
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
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Identifiers
| 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, NV…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1148-2015%22
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