Why it was recalled
Failed Stability Specifications
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 numbers, UPCs & expiration codes
Lot #: 102101, Exp: 31 July 2024
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0896-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 23, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 4240 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vivus, Inc.
Original FDA data
Every field from FDA enforcement report D-0896-2023, exactly as published.
Show all FDA fields
- City
- Campbell
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 92582
- Address
- 900 E Hamilton Ave Ste 550
- Code information
- Lot #: 102101, Exp: 31 July 2024
- Postal code
- 95008-0643
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0896-2023
- Classification
- Class III
- Recalling firm
- Vivus, Inc.
- Product quantity
- 4240 bottles
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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,
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 23, 2023
- Center classification date
- Jul 7, 2023