Recalls / Class II
Class IID-0200-2026
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.
- Affected lot / code info
- Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Park Avenue Compounding
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3662 Park Ave Ste 140, Saint Louis, Missouri 63110-2512
Distribution
- Quantity
- 858 syringes
- Distribution pattern
- MO
Timeline
- Recall initiated
- 2025-09-17
- FDA classified
- 2025-12-02
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0200-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.