Altaire Recalls Women's Tear Stimulation Dry Eye Drops for Sterility Concerns
Altaire Pharmaceuticals is recalling Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class I or USDA Class I recalls must be at least 4, and Class II recalls involving significant risk factors like sterility issues in ophthalmic products are categorized as Severe.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL (NDC 68770-103-15). The recall involves 41,925 units distributed nationwide in the United States. The specific lot codes affected are 17281 9/19 and 18120 5/20.
The recall was initiated because of a lack of assurance of sterility in the product. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have this product should stop using it and contact Altaire Pharmaceuticals for further instructions or a refund. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 41,925
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 (1)
- 17281 9/19 18120 5/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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