CVS Overnight Lubricating Eye Ointment Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling CVS Health Overnight Lubricating Eye Ointment due to a lack of assurance of sterility. The recall covers 284,232 units 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility in an ophthalmic product poses a significant risk of infection, aligning with the Severe criteria for Class II recalls with potential for serious harm.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532. The recall is being conducted because of a lack of assurance of sterility. The product is distributed by CVS Pharmacy Inc. in Woonsocket, RI.
The recall affects 284,232 units distributed nationwide in the U.S.A. The affected lot numbers are RJK 10/19, SBJ 2/20, SFG 6/20, SHI 8/20, SLB 12/20, TCM 03/21, and TDC 4/21.
Consumers should stop using the product and contact CVS Pharmacy Inc. or Altaire Pharmaceuticals for further instructions. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 284,232
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 (1)
- Lot #: RJK 10/19 SBJ 2/20 SFG 6/20 SHI 8/20 SLB 12/20 TCM 03/21 TDC 4/21
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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