CLASS II ONGOING Drug recall · Reported 20 Jul 2022 · FDA Enforcement Report

Procaine HCL 2% (20mg/mL)-vial, Refrigerate, Tailor Made Compounding recalled

TMC Acquisition is recalling Procaine HCL 2% (20mg/mL)-vial, Refrigerate, Tailor Made Compounding, distributed nationwide in the US. The recall was initiated on 7 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch#: 10112102A2, Exp 4/9/2022; 11302101A1, Exp 5/29/2022; 01242201A1, Exp 5/31/2022.
Quantity recalled58 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-1222-2022
FDA event ID
89909
Recalling firm
TMC Acquisition, Nicholasville, KY
Classification
Class II
Status
Ongoing
Recall initiated
7 Mar 2022
FDA classified
14 Jul 2022
Reported
20 Jul 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

7 Mar 2022Recall initiated by company
14 Jul 2022Classified by FDA+129 days
20 Jul 2022Published 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

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 HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding

Where it was distributed

Nationwide USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Batch#: 10112102A2, Exp 4/9/2022; 11302101A1, Exp 5/29/2022; 01242201A1, Exp 5/31/2022.

Where was it sold?

Nationwide USA and Puerto Rico

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

51 other products · FDA event 89909

This product is part of a recall event; the main page for the event is GAC (Glutamine/Arginine/L-Carnitine) recalled by TMC Acquisition.

ReportedClassRecallCompanyReasonWhere
CLASS IIGAC (Glutamine/Arginine/L-Carnitine) recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IIEstradiol Cypionate 10mg/mL, a)-vial, b)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IISemaglutide/Cyanocobalamin 5mg/0.2mg/ml-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IIPentosan Polysulfate Sodium 250mg/mL-vial, Room Temperature recalledTMC AcquisitionSterilityNationwide
CLASS IIAlprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIMethionine/Inositol/Choline B12 + Carnitine recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IIAlpha Lipoic Acid 25mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IIInositol/Choline B12 + Carnitine recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IIFolic Acid 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IIPT-141 10mg/mL a)-vial, b)-vial, Refrigerate recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IIMethylcobalamin 10mg/mL, a)-vial, b)-vial, c)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IINandrolone Decanoate 200mg/mL, a)-vial, b)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIGonadorelin 100mcg/mL per vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Cypionate (GSO) 200mg/ml a)-vial, b)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIGlutathione 200mg/mL Preservative Free, Injectable-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIVitamin D3 50,000IU/mL-vial, Room Temperature recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Enanthate (GSO) 100mg/ml-vial recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IILevocarnitine 500mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IIDexpanthenol Preservative Free 250mg/mL-vial recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IIBCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL-vial recalledTMC AcquisitionSterilityNationwide
CLASS IISermorelin 2000mcg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IIMethylcobalamin 1mg/mL, a)-vial, b)-vial, Room Temperature recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Cypionate/Propionate 180/20mg/ml, a)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIGlycyrrhizic Acid 8mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IINAD+ 200mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Enanthate (GSO) 200mg/ml, a)-vial, b)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIAnastrozole/Testosterone Cypionate/Propionate recalledTMC AcquisitionSterilityNationwide
CLASS IIMelanotan I 200mcg/mL (2mg/ml), a)-vial, b)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IISemaglutide/Cyanocobalamin 2mg/0.4mg/ml-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IITeriparatide 226mcg/ml Injectable recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IIDexpanthenol 250mg/mL-vial, Room Temperature recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IITestosterone Propionate 100mg/ml-vial, Room temperature recalledTMC AcquisitionSterilityNationwide
CLASS IIAscorbic Acid 500mg/mL, a)-vial, b)-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IICalcium Chloride Preservative Free, 100mg/mL, a)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIGOAL (Glutamine/Ornithine/Arginine/Lysine recalled by TMC AcquisitionTMC AcquisitionSterilityNationwide
CLASS IITestosterone Cypionate/Enanthate/Propionate 80/80/40mg recalledTMC AcquisitionSterilityNationwide
CLASS IIMethylcobalamin Preservative Free, 10mg/mL-vial recalledTMC AcquisitionSterilityNationwide
CLASS IISermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IIGlutathione 200mg/ml, a)-vial, b)-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IIVitamin B-Complex, a)-vial, b)-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IIMethionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Cypionate (GSO) 100mg/ml a)-vial , b)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Cypionate/Anastrozole 200mg/0.5mg/mL-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIVitamin B-Complex Preservative Free-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIHydroxocobalamin 25mg/mL-vial, Room Temperature recalledTMC AcquisitionSterilityNationwide
CLASS IIHydroxocobalamin Preservative Free 5mg/mL-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IIBiotin 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
CLASS IISermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
CLASS IITestosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalledTMC AcquisitionSterilityNationwide
CLASS IIMethylene Blue Hypotonic Solution, 10mg/mL, a)-vial recalledTMC AcquisitionSterilityNationwide

More recalls from TMC Acquisition

All 52
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIMethylene Blue Hypotonic Solution, 10mg/mL, a)-vial recalledTMC AcquisitionSterilityNationwide
DrugCLASS IITestosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalledTMC AcquisitionSterilityNationwide
DrugCLASS IISermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide
DrugCLASS IIBiotin 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
DrugCLASS IIHydroxocobalamin Preservative Free 5mg/mL-vial, Refrigerate recalledTMC AcquisitionSterilityNationwide

Other Procaine recalls

All 7
ReportedClassRecallCompanyReasonWhere
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
DrugCLASS IIProcaine Hydrochloride Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide