Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662
Summary
The FDA issued a Class II for Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, by Park Avenue Compounding. Reason: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results..
Details
Source
Drug Recall
External ID
D-0178-2026
Action Date
2025-11-26
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot # 20250507-01D93C, Exp Date: 11-04-2025
Quantity Affected: 189 bags
Reason for Recall
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Distribution
Distributed in Missouri
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-23
Company
Saint Louis, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Park Avenue Compounding has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Park Avenue Compounding) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Park Avenue Compounding have FDA actions?
Park Avenue Compounding has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0178-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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