Recalls / Class III
Class IIID-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,
- Brand name
- Pancreaze
- Generic name
- Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease
- Active ingredients
- Pancrelipase Amylase, Pancrelipase Lipase, Pancrelipase Protease
- Route
- Oral
- NDCs
- 62541-401, 62541-402, 62541-403, 62541-404, 62541-405, 62541-406
- FDA application
- BLA022523
- Affected lot / code info
- Lot #: 102101, Exp: 31 July 2024
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Vivus, Inc.
- Manufacturer
- VIVUS LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 900 E Hamilton Ave Ste 550, N/A, Campbell, California 95008-0643
Distribution
- Quantity
- 4240 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-06-23
- FDA classified
- 2023-07-07
- Posted by FDA
- 2023-07-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0896-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.