Tailor Made Compounding recalls Pentosan Polysulfate Sodium 250mg/mL vials due to lack of sterility assurance. Affected batches expired by May 2022. Consumers should check batch numbers and contact the company.
Lack of Assurance of Sterility
Tailor Made Compounding has recalled specific batches of Pentosan Polysulfate Sodium 250mg/mL vials because they may not be sterile. This could lead to infections if used improperly. Affected batches have expiration dates up to May 2022.
The vials may not have been properly sterilized, which could lead to contamination. If the product is used without proper sterility, it might cause infections in patients.
People who purchased the recalled vials for medical use are affected. Those with compromised immune systems or using the product for critical treatments may be at higher risk.
Check the vial label for batch numbers: 11292109A2 (expires May 28, 2022), 01242202A1 (expires June 18, 2022), or 03022214A1 (expires August 29, 2022).
Look for batch numbers on the vial label: 11292109A2, 01242202A1, or 03022214A1.
The vials may not be sterile, which could lead to infections if used improperly.
Check the vial label for batch numbers: 11292109A2 (expires May 28, 2022), 01242202A1 (expires June 18, 2022), or 03022214A1 (expires August 29, 2022).
The recall does not specify a remedy, so contact Tailor Made Compounding directly for guidance.
We’ve drafted a message you can send Tailor Made Compounding to request your refund or repair — edit it as you like.
Subject: Recall D-1221-2022 — Tailor Made Compounding Tailor Made Compounding Hello, I own a Tailor Made Compounding that is covered by recall D-1221-2022 from Tailor Made Compounding. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
