Natpara Injection Recall Due to Potential Needle Clogging and Underdosing
Shire is recalling Natpara (parathyroid hormone) injections because rubber stopper particles may clog the needle, potentially causing underdosing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. The rubric mandates a score of at least 4 for FDA Class I recalls.
Plain-English summary
Shire Human Genetic Therapies, Inc. is recalling Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges. The recall involves 1,556 units of the prescription medication, which is intended for subcutaneous use only. The product was distributed throughout the United States.
The recall is being issued 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. Specific lot numbers and expiration dates are identified in the recall documentation.
Patients and healthcare providers should stop using the affected Natpara cartridges and contact their healthcare provider for further instructions. Consumers should check their medication packaging for the specific lot numbers and expiration dates listed in the official recall notice to determine if their product is affected.
The recalled product
- Product
- Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
- Manufacturer
- Shire Human Genetic Therapies, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 1,556
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 (5)
- 08569357
- exp 4/30/2020
- 07983652
- 08544833
- exp 6/30/2021
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
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