Agency classClass IIOur severity:High FDA (Drugs)·D-1222-2022·Announced 2022-07-20

Procaine HCL Injectable Recalled Due to Sterility Assurance Concerns

Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: No illnesses or hospitalizations have been reported; the hazard is theoretical risk of contamination due to unconfirmed sterility. This matches the High severity criterion: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Tailor Made Compounding is recalling Procaine HCL 2% (20 mg/mL) injectable solution in 30 mL vials due to lack of assurance of sterility. The affected batches are: #10112102A2 (expires 4/9/2022), #11302101A1 (expires 5/29/2022), and #01242201A1 (expires 5/31/2022). A total of 58 vials have been distributed.

The recall covers product distributed nationwide in the United States and Puerto Rico. Injectable medications require strict sterility assurance. The company determined it could not provide adequate assurance that these vials met sterility requirements.

Consumers who have received or possess any of the recalled vials should not use them and should contact their healthcare provider or pharmacy for guidance. Healthcare facilities should quarantine any remaining stock of the affected batches.

The recalled product

Product: Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Compounded Injectable
Hazard: sterility-assurance
contamination
Affected units: 58

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

See all →

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Same hazard · sterility assurance