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 →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03
by Edge Pharma, LLC
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01
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 in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
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
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
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
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
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
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
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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