Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Digi Eye
Reason Lack of Assurance of Sterility
OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
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
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- NDC code
- 54799-503-15
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0442-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hypromellose recalls
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Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Artificial Tears Lubricant Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dry Eye Relief Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Vista Gonio Eye Lubricant
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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