FDA Recall D-0896-2023
Vivus, Inc. · Campbell, CA
Class III Ongoing 1056 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Recall record
- Recall number
D-0896-2023- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- Nationwide within the United States
- Recall initiated
- 2023-06-23
- Classified by FDA Center
- 2023-07-07
- FDA published
- 2023-07-19
- Recalling firm
- Vivus, Inc.
- Firm location
- Campbell, CA
Drug identification
- Brand name(s)
- PANCREAZE
- Generic name(s)
- PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE
- Manufacturer(s)
- VIVUS LLC
- NDC(s)
62541-401, 62541-402, 62541-403, 62541-404, 62541-405, 62541-406- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.