FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
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
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01; Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01; Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01; and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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