Vivus, Inc.

FDA Regulatory Profile

Vivus, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0896-2023, Class III) was initiated on June 23, 2023. Its most recent 510(k) clearance was granted on December 19, 2000.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0896-2023Class IIIPANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, ManufacturedJune 23, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K003115ACTIS ADJUSTABLE CONSTRICTION LOOPDecember 19, 2000
K962915ACTIS (VENOUS FLOW CONTROLLER)December 10, 1996