The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0447-2020·Announced 2019-11-27

OCuSOFT Eye Wash Recalled for Lack of Sterility Assurance

Altaire Pharmaceuticals is recalling OCuSOFT Eye Wash due to a lack of assurance of sterility. Consumers should stop using the product and contact the manufacturer.

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 potential serious, reversible health consequences.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL). The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is identified by NDC 54799-565-01 and was manufactured for OCuSOFT, Inc. in Richmond, TX. The recall covers 55,134 units distributed nationwide in the U.S.A. Specific lot codes associated with the recall include 18026, 18100, 19052, and 19130, with expiration dates ranging from January 2021 to May 2022.

Consumers who have this product should stop using it immediately. They are advised to contact Altaire Pharmaceuticals, Inc. for further instructions or a refund.

The recalled product

Product
OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
55,134

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)

  • 18026 1/21 18100 4/21 19052 2/22 19130 5/22

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.

See all 134 products in this recall →

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