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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

PANCREAZE (pancrelipase) Recalled for Failed Stability Specifications

Agency Publication Date: July 7, 2023
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Summary

Vivus, Inc. has recalled 4,240 bottles of PANCREAZE (pancrelipase) Delayed-Release Capsules because the medication failed to meet stability specifications. PANCREAZE is a prescription medication used to help the body digest food when the pancreas does not produce enough enzymes. This recall involves 100-count bottles from a single production lot, and consumers who use this medication should contact their healthcare provider to discuss their treatment.

Risk

The failure to meet stability specifications means the medication may lose its potency or performance before its expiration date. This could result in the drug being less effective at helping the body break down and absorb nutrients from food.

What You Should Do

  1. This recall affects PANCREAZE (pancrelipase) Delayed-Release Capsules sold in 100-count bottles under NDC 62541-401-10, a prescription medication for pancreatic enzyme deficiency.
  2. Check your medication bottle for lot number 102101 with an expiration date of July 31, 2024.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Vivus, Inc. directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: PANCREAZE (pancrelipase) Delayed-Release Capsules (100-count bottle)
Variants: 100-count bottles, Rx only
Lot Numbers:
102101 (Exp: 31 July 2024)
NDC:
62541-401-10

Manufactured by VIVUS LLC, Campbell, CA 95008.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92582
Status: Active
Manufacturer: Vivus, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4240 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.