[pending] Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenu
Pending LLM rewrite. Source: FDA_DRUG D-0178-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
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 — Drugs
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
Distribution scope not specified by the agency.
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