Why it was recalled
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: B120217A, Exp 05/15 - US Distribution
Where it was sold
Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-324-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 31, 2013
- FDA report date
- May 22, 2013
- Quantity
- 3,181 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gilead Sciences, Inc.
Original FDA data
Every field from FDA enforcement report D-324-2013, exactly as published.
Show all FDA fields
- City
- Foster City
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64267
- Address
- 333 Lakeside Drive
- Code information
- Lot #: B120217A, Exp 05/15 - US Distribution
- Postal code
- 94404-1147
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-324-2013
- Classification
- Class I
- Recalling firm
- Gilead Sciences, Inc.
- Product quantity
- 3,181 vials
- Termination date
- Jan 6, 2014
- Reason for recall
- Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
- Recall initiation date
- Jan 31, 2013
- Initial firm notification
- Center classification date
- May 16, 2013