Walgreens Sodium Chloride Ophthalmic Ointment Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling Walgreens Sodium Chloride Ophthalmic 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 significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 30,240 units of Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile. The product is distributed by Walgreen Co. and is identified by NDC 0363-7500-50. The specific lot affected is TCI with an expiration date of 03/21.
The recall was initiated due to a lack of assurance of sterility. The product was distributed nationwide in the United States.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- WALGREENS SODIUM CHLORIDE OPHTHALMIC 5 PERCENT HYPERTONICITY EYE (SODIUM CHLORIDE)
- Brand
- WALGREENS SODIUM CHLORIDE OPHTHALMIC 5 PERCENT HYPERTONICITY EYE
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 30,240
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 #: TCI
- Exp 03/21
UPCs (1)
- 0311917007960
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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