Altaire Recalls OCuSOFT Goniosoft Ophthalmic Solution for Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Solution 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 and involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection and potential hospitalization.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, 0.5 fl oz (15 mL) bottles. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is manufactured for OCuSOFT Inc. and carries the NDC 54799-503-15. The recall covers 75,996 units distributed nationwide in the United States. Specific lot codes and expiration dates are listed in the recall documentation, including codes 17303, 18032, 18235, 18285, 19021, and 16260.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 75,996
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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