Status
Ongoing
Drug Enforcement D-0230-2025
Presence of Particulate Matter.
Classification
Class I
Report Date
February 26, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 24640 vials
- Reason for recall
- Presence of Particulate Matter.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.
Location & Firm
- Recalling firm
- Provepharm Inc.
- Address
-
100 Springhouse Dr Ste 105, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0230-2025
- Event ID
- 96121
- Recall initiation date
- January 21, 2025
- Center classification date
- February 20, 2025
- Code info
- Lot# 24020027, Exp Date: 12/31/2025
- More code info
- —