OCuSOFT Eye Wash Sterile Isotonic 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 Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Alta…
- Recall number
- D-0448-2020
- 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 Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59
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