FDA Drug recall D-0730-2016
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton,…
- FDA Drug
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton,… by Genzyme, citing presence of Particulate Matter: Glass particles found in the product after reconstitution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0730-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Genzyme |
| Distribution | US |
Product
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.
Reason
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Identifiers
| ndc | 58468-0030-1 |
|---|---|
| ndc | 58468-0030-2 |
| ndc | 58468-1849-4 |
| code_info | Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0730-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.