Thyrogen
FDA Recall NDC 58468-1849
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Thyrogen (NDC 58468-1849). A significant event, classified as Class II, was initiated on Feb 16, 2016 by Genzyme Corporation. The reported reason for this action was: "Presence of Particulate Matter: Glass particles found in the product after reconstitution."
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
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Feb 16, 2016
Mar 09, 2016
4669 Cartons
Recall Profile & Regulatory Data
Event ID
73301
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Genzyme Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Termination Date
Mar 02, 2017
Product Description
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.
Batch or Lot Expiration Information
Lot# s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Affected Packages Involved in this Recall
58468-0030-1Product
58468-0030-2Product
58468-1849-4Product
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.
