Drug product
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
D-0154-2018
Product summary
- Firm
- ALLERGAN
- Event
- Event 78652
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,699 bottles
- Official record key
drug-enforcement:D-0154-2018
Official wording
Reason: Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Code information: Lot #: 160741A, Exp 02/18
Distribution pattern: U.S.A. nationwide
Derived failure modes
-
Potency or specification failure
Subpotent