The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0397-2020·Announced 2019-11-27

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.

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 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
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)

  • 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.

See all 134 products in this recall →

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