Park Avenue Compounding is recalling 189 bags of Fentanyl citrate and Ropivacaine in Normal Saline. This recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards, specifically involving a revised interpretation of quality control testing (Acceptable Quality Level results). These products were distributed in Missouri and are intended for clinical use.
The quality control deviations could mean the product does not meet safety or potency standards, which may result in patients receiving incorrect dosages or contaminated medication. While no specific injuries were reported, these manufacturing failures pose a moderate risk to patients receiving these injectable medications.
Distributed in Missouri. Distributed to clinical settings.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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