FDA Recall D-1251-2014

Shire Human Genetic Therapies, Inc. · Lexington, MA

Class I — life-threatening Terminated 901 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: 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.

Quantity: 8359 vials

Reason for recall

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

Recall record

Recall number: D-1251-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide including Puerto Rico; Mexico, Columbia
Recall initiated: 2014-03-14
Classified by FDA Center: 2014-04-18
FDA published: 2014-04-30
Terminated: 2016-08-31
Recalling firm: Shire Human Genetic Therapies, Inc.
Firm location: Lexington, MA

Drug identification

Brand name(s): VPRIV
Generic name(s): VELAGLUCERASE ALFA
Manufacturer(s): Takeda Pharmaceuticals America, Inc.
NDC(s): 54092-701
Route(s): INTRAVENOUS

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