Tailor Made Compounding recalls specific batches of Alprostadil/Papaverine/Phentolamine 3mL vials due to lack of sterility assurance. This could pose infection risks if used improperly.
Lack of Assurance of Sterility
Tailor Made Compounding has recalled two specific batches of Alprostadil/Papaverine/Phentolamine 3mL vials because they lack sterility assurance. Using these vials could lead to infections if the medication is not properly handled.
The vials lack sterility assurance, meaning they could be contaminated with bacteria or other pathogens. If the medication is used without proper sterilization, it could cause infections in the user.
People who own or use the recalled vials, particularly those with medical conditions requiring this medication. Those with compromised immune systems may be at higher risk.
Check for batch numbers 01042221A2 (expires 3/5/2022) or 02192216A1 (expires 4/20/2022) on the vial label. The product is a 3mL vial of Alprostadil/Papaverine/Phentolamine.
Look for batch numbers 01042221A2 or 02192216A1 on the vial label.
The recalled vials have batch numbers 01042221A2 (expires 3/5/2022) or 02192216A1 (expires 4/20/2022).
Check the vial label for batch numbers 01042221A2 or 02192216A1. The product is a 3mL vial of Alprostadil/Papaverine/Phentolamine.
The recall does not specify a remedy, so contact the manufacturer 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-1193-2022 — Tailor Made Compounding Tailor Made Compounding Hello, I own a Tailor Made Compounding that is covered by recall D-1193-2022 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.
