Altaire Recalls Ocusoft Tears Again Lubricant Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Ocusoft Tears Again Lubricant Eye Drops 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 classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported here, the lack of sterility assurance for an ophthalmic product represents a significant risk of harm, aligning with the Severe tier for Class II recalls with potential for serious adverse health consequences.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Ocusoft Tears Again Lubricant Eye Drops, 15 mL, NDC 54799-904-15. The recall was initiated because the company lacks assurance of the sterility of the affected units.
The recall involves 139,572 units distributed nationwide in the United States. The affected lots include specific lot numbers and expiration dates ranging from September 2019 to May 2021.
Consumers should stop using the recalled eye drops and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences may occur.
The recalled product
- Product
- Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 139,572
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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