CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report

Mvasi, (bevacizumab-awwb), Sterile Ophthalmic Solution recalled

Edge Pharma is recalling Mvasi, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/ (25 mg/mL), distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes11-2021-01@2 12/15/2021
Quantity recalled199 syringes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0412-2022
FDA event ID
89172
Recalling firm
Edge Pharma, Colchester, VT
Classification
Class II
Status
Terminated
Recall initiated
6 Dec 2021
FDA classified
24 Jan 2022
Reported
2 Feb 2022
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility
Drug class
Eye Drops

Timeline

6 Dec 2021Recall initiated by company
24 Jan 2022Classified by FDA+49 days
2 Feb 2022Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

11-2021-01@2 12/15/2021

Where was it sold?

nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

55 other products · FDA event 89172

This product is part of a recall event; the main page for the event is Edetate Disodium (EDTA), Sterile Ophthalmic Solution recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIEdetate Disodium (EDTA), Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
CLASS IIEdetate Disodium (EDTA), Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
CLASS IIPhenol, Topical Solution (PF) Multiple Dose Vial recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIProfound-PE Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIGemcitabine, Sterile Intravesical Solution recalled by Edge PharmaEdge PharmaSterilityNationwide
CLASS IIDibutyl Squaric Acid, Topical Solution (PF) recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIDexamethasone sodium phosphate, sterile otic solution recalledEdge PharmaSterilityNationwide
CLASS IIPhenylephrine HCl, 1mg/ (0.1mg/mL) per syringe recalled by Edge PharmaEdge PharmaSterilityNationwide
CLASS IILET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIPromethazine HCl Topical Ointment recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIVitamin K (Vitamin K ) Oral Solution (PF) recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIBetadine (povidone-iodine), Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
CLASS IICantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IILidocaine HCl/Epinephrine, Sterile Buffered Solution recalledEdge PharmaSterilityNationwide
CLASS IIBLT Topical Cream, Benzocaine/Lidocaine/Tetracaine recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIPhenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
CLASS IIMitomycin-C Sterile Ophthalmic Solution, Preservative Free recalledEdge PharmaSterilityNationwide
CLASS IIDibutyl Squaric Acid, Topical Solution recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIMoxifloxacin, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide
CLASS IILidocaine HCl / Oxymetazoline HCl Nasal Solution recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIVancomycin HCl Oral Solution (PF) 125mg recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac recalledEdge PharmaSterilityNationwide
CLASS IIProfound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIVancomycin HCl in 0.9% Sodium Chloride Injection recalled by Edge PharmaEdge PharmaSterilityNationwide
CLASS IIALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate recalledEdge PharmaSterilityNationwide
CLASS IIProfound Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIVancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg recalledEdge PharmaSterilityNationwide
CLASS IIEpinephrine/Lidocaine HCl Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
CLASS IIProfound Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIDexamethasone sodium phosphate recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIPhenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac recalledEdge PharmaSterilityNationwide
CLASS IILidocaine HCl Sterile Buffered Solution for Injection recalledEdge PharmaSterilityNationwide
CLASS IINeostigmine methylsulfate, 5 mg/ (1 mg/mL) per syringe recalledEdge PharmaSterilityNationwide
CLASS IICefuroxime, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide
CLASS IICsf-hc Otic Insufflation Capsule, Sulfacetamide recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIMitomycin-C, Sterile Ophthalmic Solution, Preservative Free recalledEdge PharmaSterilityNationwide
CLASS IIPhenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
CLASS IIPhenol, Sterile Solution for Injection (PF), 6% per vial recalledEdge PharmaSterilityNationwide
CLASS IIMitomycin-C, 40mg/ (1mg/mL) per syringe recalled by Edge PharmaEdge PharmaSterilityNationwide
CLASS IIPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac recalledEdge PharmaSterilityNationwide
CLASS IIPhenylephrine HCl 0.5 mg/, (0.1 mg/mL) per syringe recalledEdge PharmaSterilityNationwide
CLASS IICantharidin Gel-Forming Suspension, 0.7% per vial recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIMethacholine Challenge 5-Syringe Test Kit recalled by Edge PharmaEdge PharmaSterilityNationwide
CLASS IIVancomycin HCl, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide
CLASS IILidocaine HCL / Bupivacaine HCL (contains Hyaluronidase/mL) recalledEdge PharmaSterilityNationwide
CLASS IIPHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg recalledEdge PharmaSterilityNationwide
CLASS IITrypan Blue 0.03% per syringe recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IILT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IILidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1% recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIVancomycin HCl in 0.9 % Sodium Chloride Injection recalledEdge PharmaSterilityNationwide
CLASS IICeftazidime, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide
CLASS IICSF Otic Insufflation Capsule recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIMethotrexate, USP, Sterile Solution for Injection (PF) recalledEdge PharmaSterilityNationwide
CLASS IITetracaine HCl Nasal Solution recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
CLASS IIPhenylephrine HCl, Sterile Solution for Injection, (PF) recalledEdge PharmaSterilityNationwide

More recalls from Edge Pharma

All 62
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPhenylephrine HCl, Sterile Solution for Injection, (PF) recalledEdge PharmaSterilityNationwide
DrugCLASS IITetracaine HCl Nasal Solution recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIMethotrexate, USP, Sterile Solution for Injection (PF) recalledEdge PharmaSterilityNationwide
DrugCLASS IICSF Otic Insufflation Capsule recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IICeftazidime, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide