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

FDA recall notice · announced March 9, 2016 · Genzyme

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Lot/code information: Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Quantity: 4669 Cartons
Status: Terminated
Products in this recall event:
- 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, (D-0729-2016)
- 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 Wat (D-0730-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.