Altaire Recalls OCuSOFT Ophthalmic Ointment Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT retaine ophthalmic ointment because the company cannot ensure 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 sterility assurance for an ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL). The recall was initiated because the manufacturer lacks assurance of the product's sterility.
The affected product is distributed by OCuSOFT, Inc. in Rosenberg, TX, and was distributed nationwide in the U.S.A. The recall involves 13,626 units. The specific lot number is 18008, with expiration dates of 1/20 and 19105 (4/22).
Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Ointment
- Hazard
- Affected units
- 13,626
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)
- Lot #: 18008 1/20 19105 4/22
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.
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