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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4181–4200 of 17,755 recalls

Class ITerminated

kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1

Valisa MFG LLC

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility.

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

Lack of Assurance of Sterility

December 6, 2021 · DrugView details →

Class IITerminated

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

Edge Pharma, LLC

CGMP Deviations

December 6, 2021 · DrugView details →

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