Shire Recalls VPRIV Vials Due to Presence of Particulate Matter
Shire Human Genetic Therapies is recalling 8,359 vials of VPRIV (velaglucerase alfa) because they contain stainless steel and barium sulfate particles.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Shire Human Genetic Therapies, Inc. is recalling 8,359 vials of VPRIV (velaglucerase alfa for injection), a prescription-only lyophilized powder. The recall was initiated because the product was found to contain particulate matter, specifically identified as stainless steel and barium sulfate.
The affected product is distributed nationwide in the United States, including Puerto Rico, as well as in Mexico and Columbia. The recall covers specific lots with an expiration date of 10/15. In the US, the affected lot numbers are FEW13-001, FEW13-002, and FED13-006. In Mexico, the affected lot is FED 013-010, and in Columbia, the affected lot is FED 013-011.
Consumers and healthcare providers should stop using the affected vials and contact Shire Human Genetic Therapies for further instructions or a replacement. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
The recalled product
- Product
- VPRIV (VELAGLUCERASE ALFA)
- Brand
- VPRIV
- Manufacturer
- Shire Human Genetic Therapies, Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 8,359
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
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