OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment 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 retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc.…
- Recall number
- D-0453-2020
- 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 retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
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