Wise Woman Herbals Eyebright Eye Rinse Recalled for Sterility Concerns
Wise Woman Herbals is recalling Eyebright Concentrate Topical Eye Rinse because it was not manufactured under sterile conditions required for ophthalmic products.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are Severe. While no specific injuries are reported in the text, the lack of sterility in an ophthalmic product is a significant health risk warranting a Severe rating under the Class II criteria.
Plain-English summary
Earthlabs, Inc. DBA Wise Woman Herbals is recalling Eyebright Concentrate Topical Eye Rinse in 1, 2, 4, 8, 16, and 32 fl oz bottles. The recall covers specific lot numbers with best used by dates ranging from July 2013 to September 2017. The product was distributed nationwide.
The FDA classified this as a Class II recall because the product was not manufactured under sterile conditions as required for ophthalmic drug products. This lack of assurance of sterility poses a potential risk to consumers using the product on their eyes.
Consumers should stop using the recalled product and contact the manufacturer for instructions on how to return it or obtain a refund.
The recalled product
- Product
- Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
- Manufacturer
- Earthlabs, Inc. DBA Wise Woman Herbals
- Category
- Drug — Ophthalmic
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 (8)
- 2EDCO
- 4EDCO
- 8EDCO
- 16EDCO
- 2 oz.
- 4 oz. Non-stock: 8 oz.
- 16 oz.
- 32 oz.
Distribution
Distributed nationwide across the United States.
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