Class II · Moderate risk
Cidofovir Injection 375mg/5mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Vistide (cidofovir)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
61958-0101-01
Compare with the code on your package — it is the most precise check available.
Drug: Cidofovir
- Recalling firm
- Gilead Sciences, Inc.
- NDC code
- 61958-0101-1
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-324-2013 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cidofovir recalls
See all
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
Cidofovir injection 375 mg/mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Class II · Moderate risk
Cidofovir Dihydrate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Cidofovir Anhydrous active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Gilead Sciences, Inc.
All 2013 recalls
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class II · Moderate risk
Emtriva (emtricitabine)
Defective Container; leaking around the cap
Class III · Low risk
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
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