Natpara Injection Cartridges Recalled for Potential Needle Clogging
Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing 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 is defined as a serious health hazard. Per the rubric, FDA Class I recalls must be scored as 5 (Critical).
Plain-English summary
Shire Human Genetic Therapies, Inc. is recalling Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges. The recall involves 13,897 units that were distributed throughout the United States.
The recall is due to a defective delivery system where rubber stopper particles may clog the needle. This defect poses a potential risk of underdosing for patients using the medication.
Patients and healthcare providers should stop using the affected cartridges and contact their healthcare provider for further instructions. The affected lots include specific lot numbers and expiration dates listed in the recall documentation.
The recalled product
- Product
- Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
- Manufacturer
- Shire Human Genetic Therapies, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 13,897
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 (13)
- 06628461
- exp 8/31/2020 06661658
- 07110136
- 7164106
- 07761970 exp 10/31/2020 07630717
- 08689119
- exp 12/31/2020 07769458
- exp 4/30/2021 07983643
- 08003758
- exp 6/30/2021 08214790
- exp 8/31/2020 NY17002DA
- NY17002DB
- exp 6/30/2020
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
- CriticalNatpara Injection Recall Issued for Potential Needle Clogging and Underdosing
FDA (Drugs) · 2019-10-02
- SevereNatpara Injection Recall Due to Potential Needle Clogging and Underdosing
FDA (Drugs) · 2019-10-02
- CriticalShire Recalls VPRIV Vials Due to Presence of Particulate Matter
FDA (Drugs) · 2014-04-30
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