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FDAFDA · Food and drugs·Recall number D-0200-2026

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.

Published December 10, 2025 · Recall initiated: September 17, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Park Avenue Compounding
Distributor
MO
Lot
Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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