Actavis Recalls Lutera Birth Control Due to Outdated Package Inserts
Actavis Inc is recalling Lutera birth control tablets because the packs were distributed with out-dated package inserts.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The hazard is limited to outdated documentation.
Plain-English summary
Actavis Inc is recalling specific lots of Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP). The product is a 28-day regimen birth control medication manufactured for Watson Pharm, Inc. and manufactured by Patheon, Inc.
The recall was initiated because the birth control packs were distributed with out-dated package inserts. This is a labeling issue where the provided instructions may not reflect the most current information.
Consumers who have this product should check their packaging for the affected lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- 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., Mi
- Manufacturer
- Actavis Inc
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 511,283
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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