Altaire Recalls Sodium Chloride Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling specific lots of Walgreens Sodium Chloride Ophthalmic Solution because the company cannot ensure the product is sterile.
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 involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an ophthalmic product represents a significant risk of serious infection, aligning with the Severe classification for Class II recalls with potential for significant harm.
Plain-English summary
Altaire Pharmaceuticals, Inc. is voluntarily recalling specific lots of Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops. The recall is being conducted because the manufacturer lacks assurance of the product's sterility. The affected product is distributed nationwide in the United States.
The recall involves 43,008 units of the ophthalmic solution. The specific lots affected are Lot #19105 (Expiration 04/22) and Lot #19050 (Expiration 02/22). The product is identified by NDC 0363-0193-13 and is distributed by Walgreen Co.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 43,008
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 (4)
- Lot #: 19105
- Exp 04/22
- 19050
- Exp 02/22
UPCs (1)
- 0311917214177
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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