CVS Lubricant Eye Drops Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops 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 FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a sterility failure in a sterile product is categorized as Severe (Score 4) due to the potential for significant injury or infection, even without specific hospitalization reports in the text.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution) because of a lack of assurance of sterility. The recalled product consists of 30 sterile single-use containers per box, distributed by CVS Pharmacy Inc. nationwide in the United States.
The recall involves 77,760 units across multiple lots, including QHI 08/19, QJG 10/19, RBA 02/20, RCF 03/20, RCM 03/20, RDJ 04/20, RFA 06/20, RHI 08/20, RJI 10/20, RKG 11/20, SBF 2/21, and SDD 04/21. The product is identified by Item #495301 and NDC 50428 42216 8.
Consumers should check their eye drop boxes for the listed lot numbers and stop using the product if it matches the recall criteria. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 77,760
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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