OCuSOFT Goniosoft Hypromellose 2 recalled over sterility concerns
- Recall date
- July 2, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Altaire Pharmaceuticals, Inc. recalls OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO…
- Recall number
- D-0442-2020
- FDA classification
- Class II
- Brand / firm
- Altaire Pharmaceuticals, Inc.
- Sold / distributed
- U.S.A. Nationwide
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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