D-0154-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2018
- Initiation Date
- December 4, 2017
- Termination Date
- June 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,699 bottles
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.
Distribution Pattern
U.S.A. nationwide
Code Information
Lot #: 160741A, Exp 02/18