September 2025 FDA Recall Drug by Park Avenue Compounding
D-0178-2026 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Park Avenue Compounding on September 23, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in Missouri and the recall is currently ongoing.

Recall Number: D-0178-2026

Reason for Recall
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Initiated
09-23-2025
Reported
11-26-2025
Quantity
189 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97938
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Park Avenue Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Missouri
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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