FDA recall D-0896-2023

Product

PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,

Reason for recall

Failed Stability Specifications

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2023-06-23

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Campbell, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0896-2023