Vivus Pancreaze prescription drug recall for failed stability specifications
Vivus, Inc. is recalling Pancreaze delayed-release capsules nationwide due to failed stability specifications. The affected lot may not maintain product strength through the stated expiration date.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. Failed stability specifications represent a theoretical precautionary hazard; Class III recalls are typically scored 1-2 per the rubric.
Plain-English summary
Vivus, Inc. is recalling Pancreaze (pancrelipase) delayed-release capsules due to failed stability specifications. The recall involves 4,240 bottles distributed nationwide. The affected lot is Lot #102101 with an expiration date of July 31, 2024 (NDC 62541-401-10).
The product failed stability testing, which means it may not maintain its pharmaceutical strength and integrity through the stated expiration date. Pancreaze is a prescription medication containing pancreatic enzymes.
Patients who have received Pancreaze from the affected lot should contact their healthcare provider or pharmacist to determine if they have received the recalled product.
The recalled product
- Product
- PANCREAZE (PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE)
- Brand
- PANCREAZE
- Manufacturer
- Vivus, Inc.
- Category
- Drug — Prescription
- Hazard
- Affected units
- 4,240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 102101
- Exp: 31 July 2024
UPCs (7)
- 0362541402102
- 0362541403109
- 0362541405103
- 0362541401105
- 0362541406100
- 0362541404106
- 362541401105
Distribution
Distributed nationwide across the United States.
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