Pancreaze Capsule, Delayed Release
FDA Recall NDC 62541-404
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pancreaze (NDC 62541-404). A significant event, classified as Class III, was initiated on Jun 23, 2023 by Vivus Llc. The reported reason for this action was: "Failed Stability Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Stability Specifications
Jun 23, 2023
Jul 19, 2023
4240 bottles
Recall Profile & Regulatory Data
Event ID
92582
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Vivus, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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,
Batch or Lot Expiration Information
Lot# : 102101, Exp: 31 July 2024
Affected Packages Involved in this Recall
62541-402-10Product
62541-403-10Product
62541-404-10Product
62541-405-10Product
62541-401-10Product
62541-406-50Product
62541-406-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
