Food, drugs, devices › Edge Pharma, LLC
Drug recall: Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.7
Edge Pharma, LLC (Colchester, VT) initiated this drug recall on 22 Dec 2020; FDA lists 1 product record under event 87514, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 10 Jun 2021. 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
"Labeling: Incorrect or Missing Lot and/or Exp Date"
Distribution
"PA only"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0307-2021 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01 | 60 syringes | Class III | Terminated | 24 Mar 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 |
| 12 Apr 2021 | Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) | Drug | Class II | 1 |
| 17 Feb 2021 | Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharm | 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: "Labeling: Incorrect or Missing Lot and/or Exp Date"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "PA only"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Jun 2021. "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.