Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Alle...
FDA Recall #D-0154-2018 — Class II — December 4, 2017
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
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.
Recalling Firm
ALLERGAN — Madison, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12,699 bottles
Distribution
U.S.A. nationwide
Code Information
Lot #: 160741A, Exp 02/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated