Altaire Recalls OCuSOFT retaine NaCl Ophthalmic Ointment Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT retaine NaCl Ophthalmic Ointment because the product lacks 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT retaine NaCl Ophthalmic Ointment, 3.5g, SKU # 777-3-77. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product was distributed nationwide in the United States. The specific lot numbers involved are 18008, 1/20, 19105, and 4/22.
Consumers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Ointment
- Hazard
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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