CVS Health Lubricant Eye Ointment Recalled for Sterility Assurance Issues
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk defects.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Ointment Sensitive Formula, 3.5 gram, Item #247885. The product is distributed by CVS Pharmacy Inc. The recall is being conducted because of a lack of assurance of sterility.
The affected lots are QHE with an expiration date of 08/19 and QJD with an expiration date of 10/19. The product was distributed nationwide in the United States.
Consumers should stop using the product and contact CVS Pharmacy Inc. or their healthcare provider for further instructions.
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
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 (4)
- Lot #: QHE
- Exp 08/19
- QJD
- Exp 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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