D-0200-2026 Class II Ongoing
FDA drug recall D-0200-2026 was initiated by Park Avenue Compounding on September 17, 2025 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: 858 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- December 10, 2025
- Initiation Date
- September 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 858 syringes
Product Description
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 Pattern
MO
Code Information
Lot # 20250813-13D65E, Exp Date: FEB-09-2026.