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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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