Class I · High risk
Thyroid Tablets
Superpotent Drug
Natpara (parathyroid hormone)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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
Affected NDC
68875-0205-02
Compare with the code on your package — it is the most precise check available.
Drug: Thyroid
- Recalling firm
- Shire Human Genetic Therapies, Inc.
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0038-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Thyroid recalls
See all
Class II · Moderate risk
Thyroid
Subpotent Drug
Class II · Moderate risk
S.P Labs
Failed Stability Specifications
Class II · Moderate risk
S.P.Labs
Failed Stability Specifications
Class II · Moderate risk
Levothyroxine 25mcg in Ns 1.25ml Syringe
Lack of sterility assurance
Other recalls by Shire Human Genetic Therapies, Inc.
All 2019 recalls
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
VPRIV¿ (velaglucerase alfa for injection)
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
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