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.
D-0200-2026
Product summary
- Event
- Event 97960
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 858 syringes
- Official record key
drug-enforcement:D-0200-2026
Official wording
Reason: CGMP Deviations
Code information: Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Distribution pattern: MO
Derived failure modes
-
Manufacturing or process control
CGMP Deviations