OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 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 Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 7…
- Recall number
- D-0440-2020
- 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 Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
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