The Recall Desk
SevereFDA (Drugs)·D-324-2013·Announced 2013-05-22

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.

Related recalls

Same manufacturer · Gilead Sciences, Inc.

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Same hazard · particulate matter

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