Altaire Eye Ointment Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling iSolutions ActivEyes Nighttime Lubricant Eye Ointment 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile medical products where sterility assurance is compromised.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling iSolutions ActivEyes Nighttime Lubricant Eye Ointment, Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz). The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is identified by NDC 59390-190-50. The recall involves 6,877 units that were distributed nationwide in the United States. The specific lot codes associated with this recall are SKG 11/21 12/28/2018 and TAQ 01/22 04/23/2019.
Consumers who have this product should stop using it and contact Altaire Pharmaceuticals, Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 6,877
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SKG 11/21 12/28/2018 TAQ 01/22 04/23/2019
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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