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.
Reported: April 30, 2014 Initiated: March 14, 2014 #D-1251-2014
Product Description
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.
Details
- Recalling Firm
- Shire Human Genetic Therapies, Inc.
- Units Affected
- 8359 vials
- Distribution
- US Nationwide including Puerto Rico; Mexico, Columbia
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shire Human Genetic Therapies, Inc.. Units affected: 8359 vials.
Why was this product recalled? ▼
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 30, 2014. Severity: Critical. Recall number: D-1251-2014.
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