Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 160741A, Exp 02/18
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ALLERGAN
- Reason for Recall:
- Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
Product Codes/Lot Numbers:
Lot #: 160741A, Exp 02/18
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0154-2018
Related Recalls
Failed Stability Specification: out of specification for iron content.
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.