Compounded fentanyl infusion bags recalled over revised quality level interpretation
Park Avenue Compounding is recalling 189 bags of compounded fentanyl citrate and ropivacaine in sodium chloride for CGMP deviations involving a revised interpretation of AQL results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a revised interpretation of quality sampling results rather than an identified defect or reported harm.
Plain-English summary
Fentanyl citrate 2 mcg/mL with Ropivacaine 0.2% in normal saline, 150 mL bags, CII, compounded by Park Avenue Compounding of Saint Louis, Missouri, NDC 83863-4272-1, is being recalled for CGMP deviations.
The recall follows a revised interpretation of Acceptable Quality Level (AQL) results.
The recall covers 189 bags from lot 20250507-01D93C, expiring 4 November 2025. The product was distributed in Missouri. The FDA has classified the recall as Class II.
The enforcement record describes a quality assessment reinterpretation rather than an identified defect, and reports no injuries. This is a controlled substance used for infusion, so facilities holding the affected lot should quarantine it and follow the firm's instructions.
The recalled product
- Product
- Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
- Manufacturer
- Park Avenue Compounding
- Category
- Drug — Injectable
- Affected units
- 189
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 20250507-01D93C
- Exp Date: 11-04-2025
Distribution
Distributed in 1 state:
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