Drug recalls

Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Prove…

Provepharm Inc. · Presence of Particulate Matter.

Class IOngoingD-0230-2025
Status
Ongoing
City
Collegeville
State
PA
Country
United States
Classification
Class I
Product type
Drugs
Event ID
96121
Recalling firm
Provepharm Inc.
Address 1
100 Springhouse Dr Ste 105
Address 2
N/A
Postal code
19426-4709
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Nationwide in the U.S.
Recall number
D-0230-2025
Product quantity
24640 vials
Reason for recall
Presence of Particulate Matter.
Recall initiation date
20250121
Center classification date
20250220
Report date
20250226
Code info
Lot# 24020027, Exp Date: 12/31/2025
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

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.