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Genzyme Corporation

No ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, no recalls naming Genzyme Corporation are currently shown as ongoing. The 4 records below are historical recall records.

Public Health Trace has 4 recalls naming Genzyme Corporation as the recalling firm, republished from official FDA and USDA sources.

Recall history - 4 terminated records

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20163
20171
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FDA Recall TerminatedTerminated: September 10, 2020Historical recordClass III

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.

by Genzyme Corporation

Reason
Labeling: Incorrect or Missing Package Insert.
Published
November 22, 2017
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 1, 2016Historical recordClass III

Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

by Genzyme Corporation

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Published
April 6, 2016
Distribution
TN

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FDA Recall TerminatedTerminated: March 2, 2017Historical recordClass II

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.

by Genzyme Corporation

Reason
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Published
March 9, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 2, 2017Historical recordClass II

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.

by Genzyme Corporation

Reason
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Published
March 9, 2016
Distribution
Nationwide

View recall →

Showing 1–4 of 4 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Genzyme Corporation as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.

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