Edge Pharma, LLC: Drug Recall

Recall #D-0423-2022 · 12/06/2021

Class II: Risk

Recall Details

Recall Number
D-0423-2022
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
Product Quantity
1773 syringes

Reason for Recall

Lack of Assurance of Sterility

Product Description

Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01

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.