FDA Drug recall D-0896-2023
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC:…
- FDA Drug
- Class III
- ongoing
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class III recall of PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC:… by Vivus, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0896-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-06-23 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vivus |
| Distribution | US |
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
Failed Stability Specifications
Identifiers
| upc | 362541401105 |
|---|---|
| ndc | 62541-402-10 |
| ndc | 62541-403-10 |
| ndc | 62541-404-10 |
| ndc | 62541-405-10 |
| ndc | 62541-401-10 |
| ndc | 62541-406-50 |
| ndc | 62541-406-10 |
| code_info | Lot #: 102101, Exp: 31 July 2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0896-2023%22
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