FDA recall D-1251-2014

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.

Reason for recall

Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.

Distribution

US Nationwide including Puerto Rico; Mexico, Columbia

Key facts

Status

Terminated

Initiation date

2014-03-14

Report date

2014-04-30

Termination date

2016-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1251-2014