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 →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
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
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
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
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
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
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
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
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
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
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
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
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
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
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
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
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
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
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 31, 2023Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
by Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specifications.
- 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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