Altaire Recalls Equate Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Equate Support Advanced Lubricating Eye Drops because the company cannot guarantee the product is sterile.
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, and the hazard involves a lack of assurance of sterility in a sterile eye drop product, which poses a significant risk of infection or injury.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers. The recall is being conducted because the company lacks assurance of the product's sterility. The affected product is distributed by Walmart Inc. and carries NDC 49035-882-54.
The recall involves 99,420 units distributed nationwide in the U.S.A. The specific lot codes associated with this recall are RKP 11/19, RIN 09/19, SLC 12/20, RIF 09/19, TBE 02/21, TBI 02/21, and SHB 08/20.
Consumers who have purchased this product should stop using it and contact Walmart or Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 99,420
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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