PlainRecalls
FDA Drug Low Class III Ongoing

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,

Reported: July 19, 2023 Initiated: June 23, 2023 #D-0896-2023

Product Description

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

Details

Recalling Firm
Vivus, Inc.
Units Affected
4240 bottles
Distribution
Nationwide within the United States
Location
Campbell, CA

Frequently Asked Questions

What product was recalled?
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,. Recalled by Vivus, Inc.. Units affected: 4240 bottles.
Why was this product recalled?
Failed Stability Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on July 19, 2023. Severity: Low. Recall number: D-0896-2023.