Class II · Moderate risk Ongoing
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Fluorescein Sodium
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
Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Recalling firm
- Bella Pharmaceuticals, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1159-2017
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 Fluorescein recalls
See all
Class II · Moderate risk Ongoing
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
CHNaO Fluorescein Sodium Ophthalmic Strips
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class III · Low risk Ongoing
Fluorescein 2% Ophth
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Ful-Glo
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
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