# FDA recall D-0730-2016

> **Genzyme Corporation** · Class II · drug recall initiated 2016-02-16.

## 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 for recall

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

## Distribution

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

## Key facts

- **Recall number:** D-0730-2016
- **Recalling firm:** Genzyme Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-16
- **Report date:** 2016-03-09
- **Termination date:** 2017-03-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0730-2016

## Citation

> AI Analytics. FDA recall D-0730-2016. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0730-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*