Recalls / Class I
Class ID-1251-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Vpriv
- Generic name
- Velaglucerase Alfa
- Active ingredient
- Velaglucerase Alfa
- Route
- Intravenous
- NDC
- 54092-701
- FDA application
- BLA022575
- Affected lot / code info
- 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.
Why it was recalled
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Recalling firm
- Firm
- Shire Human Genetic Therapies, Inc.
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300-400 Shire Way, N/A, Lexington, Massachusetts 02421-2101
Distribution
- Quantity
- 8359 vials
- Distribution pattern
- US Nationwide including Puerto Rico; Mexico, Columbia
Timeline
- Recall initiated
- 2014-03-14
- FDA classified
- 2014-04-18
- Posted by FDA
- 2014-04-30
- Terminated
- 2016-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1251-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.