PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campb
Summary
The FDA issued a Class III for PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, R by Vivus, Inc.. Reason: Failed Stability Specifications.
Details
Source
Drug Recall
External ID
D-0896-2023
Action Date
2023-07-19
Status
Ongoing
Category
drug
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,
Lot/Code Info: Lot #: 102101, Exp: 31 July 2024
Quantity Affected: 4240 bottles
Reason for Recall
Failed Stability Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-23
Company
Campbell, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vivus, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vivus, Inc. have FDA actions?
This is the only FDA action we have on record for Vivus, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0896-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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