CLASS I Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report
Vpriv¿ (velaglucerase alfa for injection) , Lyophilized Powder recalled
Shire Human Genetic Therapies is recalling Vpriv¿ (velaglucerase alfa for injection) , Lyophilized Powder, distributed nationwide in the US. The recall was initiated on 14 Mar 2014 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1251-2014
- FDA event ID
- 67690
- Recalling firm
- Shire Human Genetic Therapies, Lexington, MA
- Brand
- Vpriv
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 14 Mar 2014
- FDA classified
- 18 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Mar 2014 | Recall initiated by company | |
| 18 Apr 2014 | Classified by FDA | +35 days |
| 30 Apr 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide including Puerto Rico; Mexico, Columbia
Questions about this recall
Is Vpriv¿ (velaglucerase alfa for injection) , Lyophilized Powder recalled?
Yes. Shire Human Genetic Therapies recalled Vpriv¿ (velaglucerase alfa for injection) , Lyophilized Powder on 14 Mar 2014. The recall is Class I and its status is Terminated. Recall number D-1251-2014.
Why was it recalled?
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Which lots are affected?
US: Lot #: FEW13-001, FEW13-002, FED13-006; Expiry: 10/15. Mexico: Lot #: FED 013-010; Expiry: 10/15. Columbia: Lot #: FED 013-011; Expiry: 10/15.
Where was it sold?
US Nationwide including Puerto Rico; Mexico, Columbia
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Shire Human Genetic Therapies
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |
| Drug | CLASS I | Natpara (parathyroid hormone) for Injection, 25 mcg/dose cartridges recalled | Shire Human Genetic Therapies | Particulate Matter | Nationwide |