Altaire ActivEyes Lubricant Eye Ointment Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling ActivEyes 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for potential serious, reversible health consequences.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 48 units of ActivEyes Lubricant Eye Ointment Preservative Free, 3.5 gram, NDC 59390-189-50. The recall was initiated because of a lack of assurance of sterility in the product.
The affected product was distributed nationwide in the United States. The specific lot code associated with this recall is SFE 06/21.
Consumers who have this product should stop using it and contact Altaire Pharmaceuticals, Inc. for further instructions or a refund.
The recalled product
- Product
- ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,NDC 59390-189-50
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 48
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)
- SFE 06/21
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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