Viokace (pancrelipase) tablets…

Date

Jan. 17, 2018

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Allergan

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

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

Quantity

12,699 bottles

Codes and lots

Lot #: 160741A, Exp 02/18

Recall started

Dec. 4, 2017

Recall number

D-0154-2018

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0154-2018. The agency record governs; check it and the company before acting.