D-0154-2018 Class II Terminated
FDA drug recall D-0154-2018 was initiated by ALLERGAN on December 4, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 20, 2019). Affected quantity: 12,699 bottles.
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