VPRIV Injection 400 Units (Shire) – Particulate Contamination (2014)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Shire Human Genetic Therapies, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Shire Human Genetic Therapies, Inc. is recalling VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human due to Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026