Genzyme Corporation recalls Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only,
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Recall notice
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Contact the company & request your remedy
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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
Source Page by GovInfoNow · govinfonow.com/recall/43143-genzyme-corporation-recalls-thyrogen-thyrotropin-alfa-for-injection-0-9 · Recall date February 16, 2016 · FDA enforcement record: FDA #D-0730-2016
Cite this page
“Genzyme Corporation recalls Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only,.” GovInfoNow, recall dated February 16, 2016. https://govinfonow.com/recall/43143-genzyme-corporation-recalls-thyrogen-thyrotropin-alfa-for-injection-0-9. Based on FDA recall #D-0730-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0730-2016%22&limit=1).
How to tell if you have this one
- Brand
Genzyme Corporation- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| 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.; Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016 | 27,022 vials | — |
| 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 Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.; Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017 | 4669 Cartons | 58468-0030-1, 58468-0030-2, 58468-1849-4 |
Contact Genzyme Corporation
We’ve drafted a message you can send Genzyme Corporation to request your refund or repair — edit it as you like.
Subject: Recall D-0730-2016 — Genzyme Corporation Genzyme Corporation recalls Thyrogen (thyrotropin alfa for injection), 0.9 mg/m Hello, I own a Genzyme Corporation recalls Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, that is covered by recall D-0730-2016 from Genzyme Corporation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0730-2016 (February 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0730-2016 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.