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,
FDA recall notice · announced July 19, 2023 · Vivus
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot #: 102101, Exp: 31 July 2024
Quantity: 4240 bottles
Status: Ongoing
Products in this recall event:
- 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, (D-0896-2023)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.