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Drug FDA Class II Ongoing cGMP deviation

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.

Park Avenue Compounding Published Nov 26, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Park Avenue Compounding or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Affected products (1)

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.

189 bags

Lot codes: 20250507-01D93C
Code info: Lot # 20250507-01D93C, Exp Date: 11-04-2025

Affected areas

Missouri

Timeline

  1. Initiated
    Sep 23, 2025
  2. Published
    Nov 26, 2025
Recall number
D-0178-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.