ALLERGAN recalls Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine,…

Recall date

December 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0154-2018

FDA classification

Class II

Brand / firm

ALLERGAN

Sold / distributed

U.S.A. nationwide

Why it was recalled

Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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