Why it was recalled
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Product 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
Lot numbers, UPCs & expiration codes
Lot #: 160741A, Exp 02/18
Where it was sold
U.S.A. nationwide
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-0154-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 4, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 12,699 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ALLERGAN
Original FDA data
Every field from FDA enforcement report D-0154-2018, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78652
- Address
- 1 Giralda Farms
- Code information
- Lot #: 160741A, Exp 02/18
- Postal code
- 07940-1027
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0154-2018
- Classification
- Class II
- Recalling firm
- ALLERGAN
- Product quantity
- 12,699 bottles
- Termination date
- Jun 20, 2019
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- U.S.A. nationwide
- Recall initiation date
- Dec 4, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2018