Altaire Sterile Eye Wash Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling Altaire Sterile Eye Wash because the company cannot guarantee the product is sterile.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the loss of sterility in an ophthalmic product is a significant safety hazard warranting a high severity rating under the Class II classification.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), NDC 59390-175-13. The recall was initiated because the company lacks assurance of the product's sterility.
The recall involves 48,542 units distributed nationwide in the United States. The affected lots include codes 17241, 17322, 18169, and 19052.
Consumers should stop using the product and contact Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 48,542
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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