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

FDA recall notice · announced January 17, 2018 · Allergan

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: U.S.A. nationwide
Lot/code information: Lot #: 160741A, Exp 02/18
Quantity: 12,699 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0154-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.