Altaire Recalls OCuSOFT Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL. The recall involves 427,280 units of the prescription-only ophthalmic solution, which is manufactured for OCuSOFT, Inc. The product is distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any specific illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The affected product is identified by specific lot codes and expiration dates listed in the recall documentation.
The recalled product
- Product
- OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 427,280
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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