Drug product
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.
D-1251-2014
Product summary
- Event
- Event 67690
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8359 vials
- Official record key
drug-enforcement:D-1251-2014
Official wording
Reason: Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
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.
Distribution pattern: US Nationwide including Puerto Rico; Mexico, Columbia
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter