CLASS II Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report
OCuSOFT Goniosoft Hypromellose 5% Ophthalmic Demulcent Solution recalled
Altaire Pharmaceuticals is recalling OCuSOFT Goniosoft Hypromellose 5% Ophthalmic Demulcent Solution, distributed nationwide in the US. The recall was initiated on 2 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0442-2020
- FDA event ID
- 83265
- Recalling firm
- Altaire Pharmaceuticals, Aquebogue, NY
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Jul 2019
- FDA classified
- 15 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 2 Jul 2019 | Recall initiated by company | |
| 15 Nov 2019 | Classified by FDA | +136 days |
| 27 Nov 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is OCuSOFT Goniosoft Hypromellose 5% Ophthalmic Demulcent Solution recalled?
Yes. Altaire Pharmaceuticals recalled OCuSOFT Goniosoft Hypromellose 5% Ophthalmic Demulcent Solution on 2 Jul 2019. The recall is Class II and its status is Completed. Recall number D-0442-2020.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22 16260 9/19
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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