Central Admixture Pharmacy Services recalls PHENYLephrine added to 0.9% sodium chloride IV bags because sanitization cycles lack validation data, risking contamination.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services recalls certain IV bags containing PHENYLephrine due to insufficient validation of sanitization cycles, which could lead to contamination. This affects healthcare facilities using these products for intravenous administration.
The IV bags lack validated sanitization cycles, meaning the cleaning process might not effectively remove contaminants. This could result in bacterial growth or contamination when the solution is used in medical settings.
Healthcare facilities that prepare IV medications with this specific product are affected. Patients receiving contaminated IV fluids could face infection risks.
Check for the product name: PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only. Look for NDC number 72196-7039-1 and lot number 36-260038, which expires October 3, 2023.
Verify the NDC number 72196-7039-1 and lot number 36-260038 on the IV bag label.
The recall indicates a lack of validation for sanitization cycles, so the product may not be sterile. Do not use until confirmed safe by the manufacturer.
The recall record does not specify a remedy, so contact Central Admixture Pharmacy Services directly for guidance.
The product was manufactured with lot number 36-260038, expiring October 3, 2023.
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-1128-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1128-2023 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.
