Altaire Goniotaire Ophthalmic Solution Recalled for Sterility Assurance Issues
Altaire Pharmaceuticals is recalling Goniotaire ophthalmic solution due to a lack of assurance of sterility. The recall affects 202,266 units distributed nationwide.
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. According to the rubric, an FDA Class II recall involving a sterile product where sterility assurance is compromised is rated as Severe (4) due to the potential for serious injury from infection, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
Altaire Pharmaceuticals, Inc. is voluntarily recalling Goniotaire (Hypromellose 2906) 2.5% Ophthalmic Demulcent Solution, a sterile prescription eye drop. The recall is being conducted because of a lack of assurance of sterility in the product. The affected product is packaged in 1/2 fl oz (15 mL) bottles and carries the NDC 59390-182-13.
The recall involves 202,266 units that were distributed nationwide in the United States. The source text does not specify specific lot numbers or expiration dates, but the product is identified by the manufacturer and NDC code.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. Altaire Pharmaceuticals is the recalling firm responsible for this action.
The recalled product
- Product
- GONIOTAIRE (HYPROMELLOSE 2906 (4000 MPA.S))
- Brand
- GONIOTAIRE
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 202,266
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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