Recent Voluntary Drug Recalls - NATPARA
NATPARA® (parathyroid hormone) for Injection
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 originating from the rubber septum ending up in it. When the rubber septum is punctured with repeated doses, it’s possible small pieces could break off into the cartridge.
|Product Name||NDC #||Lot #|
|NATPARA® (Parathyroid Hormone) for Injection 25 mcg||68875-0202-01
|NATPARA® (Parathyroid Hormone) for Injection 50 mcg||68875-0203-01
|NATPARA® (Parathyroid Hormone) for Injection 75 mcg||68875-0204-01
|NATPARA® (Parathyroid Hormone) for Injection 100 mcg||68875-0205-01
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, as the risk of harm to a patient's health may be higher 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