Provepharm Inc.

FDA Regulatory Profile

Provepharm Inc. appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0230-2025, Class I) was initiated on January 21, 2025.

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0230-2025Class IPhenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (suppJanuary 21, 2025
D-0150-2025Class IIDihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, DistribNovember 22, 2024