The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0450-2020·Announced 2019-11-27

OCuSOFT Tears Again Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 81,217 units distributed nationwide.

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 conditions.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), NDC 54799-904-15. The recall is being conducted because of a lack of assurance of sterility in the product.

The recall involves 81,217 units of the eye drops. These products were distributed nationwide in the United States. The affected lots are identified by the following codes and dates: 17209 (7/21), 18168 (7/22), 18217 (8/22), 18260 (10/22), and 19094 (4/23).

Consumers should check their eye drops for these specific lot codes. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
81,217

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)

  • 17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23

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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