Class II · Moderate risk Terminated
Edetate Disodium
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Edetate Disodium
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
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1428-10
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0401-2022
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 Edetate recalls
See all
Class II · Moderate risk Terminated
Edetate Calcium Disodium 400MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class I · High risk Terminated
Iohexol
Reason Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class II · Moderate risk Terminated
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Reason Super Potent and Failed Reconstitution Time
Class III · Low risk Terminated
Sb-4
Reason Sub Potent
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