Phenylephrine HCl Recall: Park Avenue Compounding 1000 mcg/10 mL
Announced 2025-12-10 · FDA
FDA recall on Park Avenue Compounding Phenylephrine HCl 1000 mcg/10 mL (Rx Only) in 10 mL total volume. About 189 bags distributed in Missouri are involved, Lot 20250507-01D93C, expiring 11-04-2025. The recall is due to CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
| Brand | Park Avenue Compounding |
|---|---|
| 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. |
| Reason | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. |
| Severity | moderate |
| Units affected | 858 |
| Distribution | Distributed in Missouri |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any products from Lot 20250507-01D93C.
- If you have this product, stop using it and contact Park Avenue Compounding for disposal or return instructions.
- Check your packaging to verify the lot number and keep the product or packaging for reference.
- If you experienced any health issues, contact your healthcare provider and report the concern to the appropriate authorities.
How to identify the recalled item
| Lot / date codes | Lot # 20250507-01D93C, Exp Date: 11-04-2025 |
|---|---|
| Lot / date codes | Lot # 20250813-13D65E, Exp Date: FEB-09-2026. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.