Park Avenue Compounding recalls specific fentanyl and ropivacaine solution due to quality control deviations in manufacturing processes.
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Park Avenue Compounding has recalled a specific fentanyl citrate and ropivacaine solution product due to quality control issues in manufacturing. This recall affects patients who may have been prescribed this medication, as it could pose risks related to improper quality standards.
The product was manufactured with deviations in quality control processes, specifically related to the Acceptable Quality Level (AQL) results. This could potentially lead to inconsistent medication quality, though the exact risk to patients is not clearly specified in the recall notice.
Patients prescribed this specific fentanyl and ropivacaine solution by a healthcare provider. Those using the product without a prescription are not affected.
Check for the product name 'Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL' with the lot number 20250507-01D93C and expiration date 11-04-2025. The product is a prescription-only medication sold by Park Avenue Compounding.
Verify the lot number and expiration date on the product label to confirm if it matches the recalled items.
The recall notice states there were quality control deviations, but does not specify if the product is safe for use. Patients should not use it without consulting their healthcare provider.
The recall notice does not mention a replacement or remedy, so patients should contact their healthcare provider for guidance.
The recall notice does not specify a remedy, so patients should check with their healthcare provider or contact Park Avenue Compounding directly for instructions.
We’ve drafted a message you can send Park Avenue Compounding to request your refund or repair — edit it as you like.
Subject: Recall D-0178-2026 — Park Avenue Compounding Park Avenue Compounding Hello, I own a Park Avenue Compounding that is covered by recall D-0178-2026 from Park Avenue 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.
