June 2023 FDA Recall Pancreaze by Vivus, Inc.
D-0896-2023 - Failed Stability Specifications
This Class III drug recall was voluntarily initiated by Vivus, Inc. on June 23, 2023 for the product Pancreaze. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0896-2023
Failed Stability Specifications
06-23-2023
07-19-2023
4240 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Vivus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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,
Batch or Lot Expiration Information
Lot# : 102101, Exp: 31 July 2024
