FDA-Drug2018-01-17Class II

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

ALLERGAN
Hazard

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

Sold states
U.S.A. nationwide
Affected count
12,699 bottles
Manufactured in
1 Giralda Farms, N/A, Madison, NJ, United States
Products
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

Official notice

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

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