Drug recall: Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only…

Class II FDA enforcement event 73301. Recall start date: 16 Feb 2016. Status in the FDA record: Terminated. Termination date: 2 Mar 2017.

Reason for recall, in the words of FDA

Presence of Particulate Matter: Glass particles found in the product after reconstitution.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Genzyme Corporation started this drug recall on 16 Feb 2016. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class II. FDA event 73301 has 2 product records. The first FDA enforcement report date is 9 Mar 2016. The record gives the status Terminated, with the termination date 2 Mar 2017.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.

Recalling firm

Genzyme Corporation, Cambridge, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 73301: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0729-2016	Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.	27,022 vials	Class II	Terminated	9 Mar 2016
D-0730-2016	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…	4669 Cartons	Class II	Terminated	9 Mar 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2016: 288
Share of these events in Class II: 46%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 4

Other events of the firm

Other FDA enforcement events of Genzyme Corporation
Initiated	Product (first record)	Type	Class	Records
12 Oct 2017	Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg	Drug	Class III	1
8 Dec 2015	Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation	Drug	Class III	1
13 Jun 2012	seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicate	Device	Class II	2

Genzyme Corporation: all 4 events

Official channels

FDA enforcement report D-0729-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 73301. https://recallregister.com/fda/ii/73301/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
What quantity of product is in FDA event 73301?: The event has 2 product records. The first record gives this quantity: 27,022 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2016 have the same class?: 46% of the 288 drug events that started in 2016 are in Class II.