Altaire Sterile Eye Wash Recalled Due to Sterility Assurance Concerns
Altaire Pharmaceuticals is recalling Altaire Sterile Eye Wash, 30 mL, because the product may not be sterile. Consumers should stop using the product and contact the manufacturer.
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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences is categorized as Severe (Score 4), particularly given the risk of infection from non-sterile eye products.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Altaire Sterile Eye Wash, 30 mL (1 fl oz.), NDC 59390-175-18, due to a lack of assurance of sterility. The recall affects 414,346 units distributed nationwide in the United States. The affected lots are identified by the following codes: 17200 (7/19), 17322 (10/20), 18026 (1/21), 18100 (4/21), 18236 (9/21), and 19052 (2/22).
The FDA 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. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers should stop using the recalled product immediately. They should contact Altaire Pharmaceuticals, Inc. for further instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 414,346
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)
- 17200 7/19 17322 10/20 18026 1/21 18100 4/21 18236 9/21 19052 2/22
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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