FDA recall D-0154-2018

ALLERGAN · Class II · 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

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

U.S.A. nationwide

Key facts

Status: Terminated
Initiation date: 2017-12-04
Report date: 2018-01-17
Termination date: 2019-06-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0154-2018