On September 5, 2019 Takeda Pharmaceutical Company Limited, manufacturer of NATPARA® (parathyroid hormone) for Injection, issued a voluntary recall of all lots of this product. This recall was issued because of the potential risk of rubber particles in the cartridge. Small pieces of rubber may break off when the rubber septum is punctured multiple times for repeated doses.

Affected NDCs

Product Name	NDC #	Lot #
NATPARA® (Parathyroid Hormone) for Injection 25 mcg	68875-0202-01 68875-0202-02	All
NATPARA® (Parathyroid Hormone) for Injection 50 mcg	68875-0203-01 68875-0203-02	All
NATPARA® (Parathyroid Hormone) for Injection 75 mcg	68875-0204-01 68875-0204-02	All
NATPARA® (Parathyroid Hormone) for Injection 100 mcg	68875-0205-01 68875-0205-02	All

 

What do you need to do?

• Do not stop taking your medication without speaking with your doctor. The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, because of the potential risk of harm to a patient's health if the treatment is stopped immediately without any alternative treatment.
• Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption. 

For more information

For more information, if you have not already been contacted by Takeda or to report any adverse events or quality problems experienced with the use of this product, contact Takeda Pharmaceuticals Limited toll free at 1.866.888.0660 or visit www.takeda.com. You can also report this to the FDA's MedWatch Program.

To report an adverse event to the FDA Med Watch Program:

• Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
• Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda or submit by fax to 1-800-FDA-0178