Altaire Recalls Ocusoft Goniosoft Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Ocusoft Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility issues in ophthalmic products which carry significant risk of infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Ocusoft Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, 15 mL, manufactured for Ocusoft, Inc. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is identified by the NDC 54799-503-15. The recall includes specific lot codes and expiration dates: 16260 (9/19), 17303 (10/20), 18032 (2/21), 18235 (9/21), 18285 (11/21), and 19021 (1/22). The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
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)
- 16260 9/19 17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22
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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