CLASS II Drug recall · Reported 22 May 2013 · FDA Enforcement Report

Procaine Hydrochloride Injection, all strengths recalled by FVS Holdings

FVS Holdings is recalling Procaine Hydrochloride Injection, all strengths and all presentations, including a), distributed nationwide in the US. The recall was initiated on 10 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 20130405-B, Exp 7/5/2013
Quantity recalled70 vials

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-401-2013
FDA event ID
64879
Recalling firm
FVS Holdings, Henderson, NV
Classification
Class II
Status
Terminated
Recall initiated
10 Apr 2013
FDA classified
16 May 2013
Reported
22 May 2013
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility

Timeline

10 Apr 2013Recall initiated by company
16 May 2013Classified by FDA+36 days
22 May 2013Published in enforcement report+6 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: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

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

Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Which lots are affected?

Lot #: a) 20130405-B, Exp 7/5/2013

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

77 other products · FDA event 64879

This product is part of a recall event; the main page for the event is Medroxyprogesterone Acetate Injection, all strengths recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedroxyprogesterone Acetate Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIMIC Vitamin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIMethylprednisolone and Dexamethasone Injection recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIBacteriostatic Water for Injection, all presentations including recalledFVS HoldingsSterilityNationwide
CLASS IIBuprenorphine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IITestosterone Cypionate and Testosterone Propionate recalledFVS HoldingsSterilityNationwide
CLASS IIBupivacaine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIDexamethasone Sodium Phosphate Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IITaurine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIMagnesium Sulfate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIBupivacaine and Dexamethasone Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIAscorbic Acid Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIEstradiol Valerate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIMethylprednisolone and Bupivacaine Injection recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIMethylprednisolone Acetate and Marcaine Injection recalledFVS HoldingsSterilityNationwide
CLASS IITestosterone Cypionate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIGlycerin/Lidocaine/Epinephrine Injection including Glycerin recalledFVS HoldingsSterilityNationwide
CLASS IIDimethyl Sulfoxide (Dmso) Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIMetoprolol Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIHyaluronidase Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IILidocaine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIVitamin D3 Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIMethylprednisolone Acetate Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IISodium Chloride and Dexamethasone Injection recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIL-Carnitine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIFurosemide Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIDimercapto-propane-sulfonic acid (DMPS) Injection recalledFVS HoldingsSterilityNationwide
CLASS IIAmikacin Injection, all strengths and all presentations including recalledFVS HoldingsSterilityNationwide
CLASS IIBetamethasone Combination with Lidocaine recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IILipotropic With Vitamins, Carnitine, Chromium recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IICyanocobalamin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIZinc Sulfate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIBet-ace-lido-6-2 Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IISodium Chloride Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IISodium Tetradecyl Sulfate Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IILipotropic With Vitamin Injections, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIGentamicin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIBetamethasone Sodium Phosphate Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIL-Glutathione Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IICyclosporine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIKetorolac Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIHydroxyprogesterone Caproate Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIAcetylcysteine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IITestosterone Propionate, Testosterone Cypionate recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIMagnesium Chloride Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IITriamcinolone Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IISodium Bicarbonate and Lidocaine Injection recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIB-Complex Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIED Mix Injections, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIBetamethasone Acetate and Betamethasone Sodium Injection recalledFVS HoldingsSterilityNationwide
CLASS IINandrolone Decanoate and Testosterone Cypionate Injection recalledFVS HoldingsSterilityNationwide
CLASS IINandrolone Decanoate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IILipotropic With Vitamins with Methylcobalamin Injections recalledFVS HoldingsSterilityNationwide
CLASS IIL-Lysine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIBetamethasone Combination Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIManganese Sulfate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIBiotin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIMethylcobalamin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIPhosphatidylcholine and Sodium Deoxycholate Injection recalledFVS HoldingsSterilityNationwide
CLASS IIMethylprednisolone, Lidocaine recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIAlpha Lipoic Acid Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIModified Myers Cocktail Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIFolic Acid Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIEstradiol Cypionate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIHydrochloric Acid Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIThiamine Hydrochloride Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIEdetate Disodium Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIPhenylephrine Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIDexpanthenol Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIEdetate Calcium Disodium Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIPyridoxine Hydrochloride Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIHuman Chorionic Gonadotropin Injection, all strengths recalledFVS HoldingsSterilityNationwide
CLASS IIHydrogen Peroxide Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIHydroxocobalamin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIPolidocanol Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IIProgesterone Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
CLASS IISodium Bicarbonate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide

More recalls from FVS Holdings

All 78
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISodium Bicarbonate Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
DrugCLASS IIProgesterone Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
DrugCLASS IIPolidocanol Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
DrugCLASS IIHydroxocobalamin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
DrugCLASS IIHydrogen Peroxide Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide

Other Procaine recalls

All 7
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIProcaine HCL 2% (20mg/mL)-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
DrugCLASS IIProcaine HCL 20 MG/ML (Mdv) Injectable Solution per vial recalledRXQ CompoundingSterilityNationwide
DrugCLASS IIProcaine HCl, 2% injection vial recalled by Promise PharmacyPromise PharmacySterilityNationwide
DrugCLASS IIProcaine HCl Injection 1%, 2%, Rx recalled by Western DrugWestern DrugSterilityNationwide
DrugCLASS IIProcaine 1% Injectable and vials recalled by The Compounding ShopThe Compounding ShopSterility4 states