Natpara Injection Recall Issued for Potential Needle Clogging and Underdosing
Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Shire Human Genetic Therapies, Inc. is recalling Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges. The recall involves 8,003 units of the prescription medication, which is intended for subcutaneous use only. The product was distributed throughout the United States.
The recall was initiated due to a defective delivery system. There is a potential risk that rubber stopper particles may clog the needle, which could lead to underdosing of the medication. The affected lots include specific lot numbers and expiration dates ranging from December 31, 2019, to June 30, 2021.
Patients using Natpara should contact their healthcare provider for guidance on alternative treatments or further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
- Manufacturer
- Shire Human Genetic Therapies, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 8,003
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 06828752
- exp 12/31/2019 07110118
- exp 4/30/2021 07164107
- exp 12/31/2019 07200436
- 07301074
- exp 4/30/2021 07482212
- 07630715
- exp 6/30/2021 07769460
- exp 4/30/2021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Shire Human Genetic Therapies, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Shire Human Genetic Therapies, Inc.
See all →- SevereNatpara Injection Cartridges Recalled for Potential Needle Clogging
FDA (Drugs) · 2019-10-02
- SevereNatpara Injection Recall Due to Potential Needle Clogging and Underdosing
FDA (Drugs) · 2019-10-02
- CriticalNatpara Injection Cartridges Recalled for Potential Needle Clogging
FDA (Drugs) · 2019-10-02
- CriticalShire Recalls VPRIV Vials Due to Presence of Particulate Matter
FDA (Drugs) · 2014-04-30
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