Recall
FDAHealthSeptember 17, 2025

Park Avenue Compounding — 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.

⚠️ CGMP Deviations

Is this relevant to me?

Geography
MO
Source agency
FDA
Category
Health
Published
September 17, 2025

MO

What's affected?

Product
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.
Lot code
20250813-13D65E

Additional details

Lot # 20250813-13D65E, Exp Date: FEB-09-2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 858 syringes.

View original FDA notice →

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