Armour Thyroid Tablet
FDA Recall NDC 0456-0458
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Armour Thyroid (NDC 0456-0458). A significant event, classified as Class II, was initiated on Jan 26, 2022 by Allergan, Inc.. The reported reason for this action was: "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions."
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: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
1 unit
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
Batch or Lot Expiration Information
Batch# Batch W05543
Affected Packages Involved in this Recall
0456-0457-01Product
0456-1045-01Product
0456-0458-01Product
0456-0458-11Product
0456-0458-63Product
0456-0459-01Product
0456-0459-11Product
0456-0459-63Product
0456-0460-01Product
0456-0461-01Product
0456-0461-11Product
0456-0461-63Product
0456-0462-01Product
0456-0463-01Product
0456-0464-01Product
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.
