D-0230-2025 Class I Ongoing
FDA drug recall D-0230-2025 was initiated by Provepharm Inc. on January 21, 2025 and is designated Class I. Reason for recall: Presence of Particulate Matter. The recall status is ongoing. Affected quantity: 24640 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 26, 2025
- Initiation Date
- January 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24640 vials
Product Description
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
Reason for Recall
Presence of Particulate Matter.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot# 24020027, Exp Date: 12/31/2025