Food, drugs, devices › Edge Pharma, LLC
Drug recall: Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT)
Edge Pharma, LLC (Colchester, VT) initiated this drug recall on 12 Apr 2021; FDA lists 1 product record under event 87710, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 11 Feb 2022. Initiation: voluntary: firm initiated. Edge Pharma, LLC has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Edge Pharma, LLC, Colchester, VT.
Reason for recall
"Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility"
Distribution
"Nationwide in the US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0335-2021 | Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178 | 5850 syringes | Class II | Terminated | 28 Apr 2021 |
Context
Other enforcement events for Edge Pharma, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Dec 2021 | ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Phar | Drug | Class II | 56 |
| 17 Feb 2021 | Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharm | Drug | Class III | 1 |
| 22 Dec 2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.7 | Drug | Class III | 1 |
| 2 Jul 2020 | Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01 | Drug | Class II | 1 |
| 19 Mar 2020 | Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRI | Drug | Class II | 1 |
| 19 Mar 2020 | Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. K | Drug | Class II | 1 |
All 7 events for Edge Pharma, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the US"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Feb 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.