Why it was recalled
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
US Nationwide including Puerto Rico; Mexico, Columbia
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1251-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 14, 2014
- FDA report date
- Apr 30, 2014
- Quantity
- 8359 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shire Human Genetic Therapies, Inc.
Original FDA data
Every field from FDA enforcement report D-1251-2014, exactly as published.
Show all FDA fields
- City
- Lexington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 67690
- Address
- 300-400 Shire Way
- Code information
- 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.
- Postal code
- 02421-2101
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1251-2014
- Classification
- Class I
- Recalling firm
- Shire Human Genetic Therapies, Inc.
- Product quantity
- 8359 vials
- Termination date
- Aug 31, 2016
- Reason for recall
- Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- US Nationwide including Puerto Rico; Mexico, Columbia
- Recall initiation date
- Mar 14, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2014