FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- 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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