CVS Health Lubricant Eye Ointment Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Ointment due to a lack of assurance of sterility. The product is distributed nationwide.
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. According to the rubric, an FDA Class II recall involving a sterile medical product where sterility assurance is compromised is rated as Severe (4) due to the potential for significant injury from infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781. The recall is being conducted because of a lack of assurance of sterility in the product. The ointment is distributed by CVS Pharmacy Inc. and was available nationwide in the United States.
The recall affects specific lots of the product, including SAS 1/21, SIA 9/21, SFE 6/21, RIE 9/20, REH 5/20, RAD 1/20, and TAH 1/22. Consumers should check their medication for these lot numbers. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
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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