Altaire Sterile Eye Wash Recalled Due to 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 recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance for a product intended for use on the eyes, which poses a significant risk of infection or injury.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Altaire Sterile Eye Wash, 118 mL (4 fl oz), NDC 59390-175-35. The recall is being conducted because the company lacks assurance of the product's sterility.
The recall affects 809,600 units distributed nationwide in the United States. The affected lots include codes 17087, 17088, 17109, 17110, 17306, 17307, 17318, 17323, 18014, 18045, 18059, 18063, 18117, 18134, 18228, 18261, 19119, 16207, 16233, 16250, 16268, and 16301, with expiration dates ranging from August 2019 to October 2022.
Consumers should stop using the recalled product and contact Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 809,600
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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