FDA-Drug2021-06-02Class II

Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
1529 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0417-2021

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