Thyrogen — Class II drug recall D-0729-2016
Terminated recall by Genzyme Corporation, reported 2016-03-09, distributed nationwide. Presence of Particulate Matter: Glass particles found in the product after reconstitution.
| Recall number | D-0729-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genzyme Corporation, Cambridge, MA, United States |
| Recall initiated | 2016-02-16 |
| Classified | 2016-02-26 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, IL, MY, TW |
| Quantity | 27,022 vials |
| Reason classes | foreign material, specification failure |
| NDC | 58468-1849-04 |
| Lot numbers | E4029Y02 |
| Expiration dates | 2016-09 |
Product
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.
Reason for recall
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0729-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.