Genzyme recalls

Genzyme appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2017-11-22.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Neth…
  FDA Drug · Class III · 2017-11-22 · Genzyme
  Reason: Labeling: Incorrect or Missing Package Insert.
• Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 021…
  FDA Drug · Class III · 2016-04-06 · Genzyme
  Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
• Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton…
  FDA Drug · Class II · 2016-03-09 · Genzyme
  Reason: Presence of Particulate Matter: Glass particles found in the product after reconstitution.
• 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 · 2016-03-09 · Genzyme
  Reason: Presence of Particulate Matter: Glass particles found in the product after reconstitution.
• seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patie…
  FDA Device · Class II · 2012-06-27 · Genzyme
  Reason: Sterility of product may be compromised due to packaging defect
• seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients…
  FDA Device · Class II · 2012-06-27 · Genzyme
  Reason: Sterility of product may be compromised due to packaging defect