Altaire Recalls Equate Night & Day Restore Tears Lubricant Eye Pack
Altaire Pharmaceuticals is recalling Equate Night & Day Restore Tears Lubricant Eye Pack 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 classification is FDA Class II, which corresponds to a Severe severity score per the rubric, as it involves a risk of temporary or medically reversible health consequences.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Equate Night & Day Restore Tears Lubricant Eye Pack, distributed by Wal-Mart Stores Inc. The recall involves 55,772 units of the product in 3.5g and 15mL package sizes, with NDC 49035-883-59. The affected lots are KT19146, KT18133, KT18194, and KT18129, which were distributed nationwide in the U.S.A.
The recall was initiated due to a lack of assurance of sterility. This classification indicates that use of the product could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-883-59
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 55,772
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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