D-1251-2014 Class I Terminated
FDA drug recall D-1251-2014 was initiated by Shire Human Genetic Therapies, Inc. on Mar 14, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. The recall status is terminated (terminated Aug 31, 2016). Affected quantity: 8359 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 30, 2014
- Initiation Date
- Mar 14, 2014
- Termination Date
- Aug 31, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8359 vials
Product description
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.
Reason for recall
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Distribution pattern
US Nationwide including Puerto Rico; Mexico, Columbia
Code information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1251-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026