Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
VPRIV¿ (velaglucerase alfa for injection)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04.
Affected NDC
54092-0701-04
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Vpriv velaglucerase alfa NDC 54092-0701 |
2.5 mg/mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Takeda Pharmaceuticals America, Inc. | Rx |
- Recalling firm
- Shire Human Genetic Therapies, Inc.
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1251-2014 · 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 recalls by Shire Human Genetic Therapies, Inc.
All 2014 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
Other particulate / foreign matter recalls from 2014
All particulate / foreign matter recalls
Class II · Moderate risk
Children's Loratadine Syrup
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
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