Altaire Lubricant Eye Drops Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling 35,896 units of Lubricant Eye Drops Moisturizing due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no injuries are reported here, the lack of sterility assurance in an ophthalmic product is a significant hazard that aligns with the Severe tier for Class II drug recalls where the risk is not theoretical but a failure of a critical quality attribute.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 35,896 units of Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL). The product is distributed by Walgreens Co. and was sold nationwide in the United States. The specific lot affected is Lot #19095 with an expiration date of 04/21.
The recall was initiated because of a lack of assurance of sterility. The source text does not specify the cause of the sterility issue or report any illnesses or injuries associated with the product.
Consumers should check their inventory for the specific lot number and expiration date listed above. If they possess the affected product, they should stop using it and contact the recalling firm or their point of purchase for instructions on return or disposal.
The recalled product
- Product
- Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, Item #801483
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 35,896
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 (2)
- Lot #: 19095
- Exp 04/21
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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