CVS Lubricant Eye Ointment Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Ointment Sensitive Formula 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk contexts are rated as Severe (4).
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Ointment Sensitive Formula, Item #247885, 3.5 gram. The product is distributed by CVS Pharmacy, Inc. The recall involves 24,024 units that were distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. The affected product codes are QHE 08/19 and QJD 10/19.
Consumers should stop using the recalled product and contact CVS Pharmacy or Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 24,024
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)
- QHE 08/19 QJD 10/19
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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