FDA recall D-0200-2026

Park Avenue Compounding · Class II · drug

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.

Reason for recall

CGMP Deviations

Distribution

MO

Key facts

Status
Ongoing
Initiation date
2025-09-17
Report date
2025-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0200-2026