Altaire Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling Fluorescein Sodium and Proparacaine Hydrochloride 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. Per the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in an ophthalmic product) are rated as Severe (4).
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only. The recall is being conducted due to a lack of assurance of sterility in the product.
The affected product is identified by NDC 59390-205-05 and was distributed nationwide in the United States. The recall covers 532,961 units. Specific lot codes and expiration dates are listed in the official recall documentation.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider or Altaire Pharmaceuticals for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE (FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE)
- Brand
- FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 532,961
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0756641205051
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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