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.

FDA recall notice · announced May 22, 2013 · Gilead Sciences

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Reason for recall

Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).

Notes

Distribution: Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Lot/code information: Lot #: B120217A, Exp 05/15 - US Distribution
Quantity: 3,181 vials
Status: Terminated
Products in this recall event:
- 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. (D-324-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.