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.
What this means for you
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
- 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
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.
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