Altaire Recalls ActivEyes Sterile Altalube Ointment Due to Sterility Concerns
Altaire Pharmaceuticals is recalling ActivEyes Sterile Altalube Ointment because the company cannot guarantee the product is sterile. Consumers should stop using the product and return it to the pharmacy.
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 sterility assurance for an ophthalmic product, which poses a risk of harm even without reported injuries.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling ActivEyes Sterile Altalube Ointment, a 1/8 oz (3.5g) ophthalmic product containing mineral oil and petrolatum. The recall was initiated because the company lacks assurance of the product's sterility. The affected product is identified by NDC 59390-198-50 and includes specific lot codes such as RJH, RLL, SGH, SIF, SKC, and TCG.
The recall covers 161,077 units that were distributed nationwide in the United States. Because the product is intended for ophthalmic use, the lack of sterility assurance presents a potential risk to patients. Altaire Pharmaceuticals is the recalling firm responsible for this action.
Consumers who have purchased this product should stop using it immediately. They should return the product to the pharmacy or place of purchase for a refund or replacement. Patients should consult their healthcare provider if they have any concerns regarding the use of this product.
The recalled product
- Product
- ALTALUBE (MINERAL OIL AND PETROLATUM)
- Brand
- ALTALUBE
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 161,077
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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