FDA-Drug2023-07-19Class III

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,

Vivus, Inc.
Hazard

Failed Stability Specifications

Sold states
Nationwide within the United States
Affected count
4240 bottles
Manufactured in
900 E Hamilton Ave Ste 550, N/A, Campbell, CA, United States
Products
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,

Official notice

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

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