Gilead Recalls Vistide Injection Due to Particulate Matter
Gilead Sciences is recalling Vistide (cidofovir) injection vials because particulate matter was found in some units. The recall covers 3,181 vials distributed in the US, Canada, and UK.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Gilead Sciences, Inc. is recalling 3,181 vials of Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vials. The recall is due to the presence of particulate matter found in some vials.
The affected product is identified by Lot # B120217A with an expiration date of 05/15. The recall covers distribution in the United States, Canada, and the United Kingdom. The Cork, Ireland facility distributed the product to Germany, Austria, Italy, and Spain.
Healthcare providers and patients should stop using the affected vials and contact Gilead Sciences for further instructions or replacement.
The recalled product
- Product
- Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.
- Manufacturer
- Gilead Sciences, Inc.
- Category
- Drug — Antiviral Injection
- Hazard
- Affected units
- 3,181
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 (2)
- Lot #: B120217A
- Exp 05/15 - US Distribution
Distribution
Distributed nationwide across the United States.
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