Central Admixture Pharmacy Services recalls fentanyl 1.5 mcg/mL and bupivacaine solutions due to lack of validation data for sanitization cycles, risking contamination.
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services is recalling fentanyl 1.5 mcg/mL and bupivacaine 0.125% solutions because their sterilization process wasn't validated, which could lead to contamination. This is a serious risk for medical use, especially in procedures requiring sterile injections.
The recall states there's a lack of validation data for sanitization cycles, meaning the products might not be sterile. This could lead to infections if the medication is injected into the body.
Healthcare providers and patients receiving these medications through prescription. Those using the recalled products for anesthesia or pain management are at risk of infection.
Check for the product name 'fentanyl 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride', 50 mL syringes, and lot numbers 17-270811 to 17-273436 with specific expiration dates.
Look for the product name, 50 mL syringe, and lot numbers listed in the recall notice.
The recall is due to a lack of validation data for sanitization cycles, which could mean the products are not sterile.
The recall notice does not specify a remedy, so contact Central Admixture Pharmacy Services for guidance.
Yes, lot numbers 17-270811 to 17-273436 with specific expiration dates listed in the recall.
We’ve drafted a message you can send Central Admixture Pharmacy Services to request your refund or repair — edit it as you like.
Subject: Recall D-1067-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1067-2023 from Central Admixture Pharmacy Services. 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.
