Edge Pharma, LLC: Drug Recall

Recall #D-0401-2022 · 12/06/2021

Class II: Risk

Recall Details

Recall Number
D-0401-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Edge Pharma, LLC
Status
Terminated
Date Initiated
12/06/2021
Location
Colchester, VT, United States
Voluntary/Mandated
Voluntary: Firm initiated

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

nationwide

Other Recalls by Edge Pharma, LLC

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.