PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0417-2021

Product Description

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

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
1529 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612. Recalled by Cardinal Health Inc.. Units affected: 1529 bottles.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0417-2021.