Drug product
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
D-0230-2025
Product summary
- Firm
- Provepharm Inc.
- Event
- Event 96121
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 24640 vials
- Official record key
drug-enforcement:D-0230-2025
Official wording
Reason: Presence of Particulate Matter.
Code information: Lot# 24020027, Exp Date: 12/31/2025
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter