Tirosint Capsule
FDA Recall NDC 71858-0017
Latest: Class II · Status: Terminated · Initiated Mar 15, 2021 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tirosint (NDC 71858-0017). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Ibsa Pharma Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
25 boxes
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES
Batch or Lot Expiration Information
Lot# 200606
Affected Packages Involved in this Recall
71858-0013-4Tirosint
71858-0013-1Tirosint
71858-0013-2Tirosint
71858-0012-4Tirosint
71858-0012-1Tirosint
71858-0012-2Tirosint
71858-0005-4Tirosint
71858-0005-1Tirosint
71858-0005-2Tirosint
71858-0010-4Tirosint
71858-0010-1Tirosint
71858-0010-2Tirosint
71858-0015-4Tirosint
71858-0015-1Tirosint
71858-0015-2Tirosint
71858-0020-4Tirosint
71858-0020-1Tirosint
71858-0020-2Tirosint
71858-0025-4Tirosint
71858-0025-1Tirosint
71858-0025-2Tirosint
71858-0030-4Tirosint
71858-0030-1Tirosint
71858-0030-2Tirosint
71858-0035-4Tirosint
71858-0035-1Tirosint
71858-0035-2Tirosint
71858-0040-4Tirosint
71858-0040-1Tirosint
71858-0040-2Tirosint
71858-0045-4Tirosint
71858-0045-1Tirosint
71858-0045-2Tirosint
71858-0050-4Tirosint
71858-0050-1Tirosint
71858-0050-2Tirosint
71858-0055-4Tirosint
71858-0055-1Tirosint
71858-0055-2Tirosint
71858-0060-4Tirosint
71858-0060-1Tirosint
71858-0060-2Tirosint
71858-0017-4Tirosint
71858-0017-1Tirosint
71858-0017-2Tirosint
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
