Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for...

FDA Drug Recall #D-324-2013 — Class I — January 31, 2013

Recall Summary

Recall Number D-324-2013
Classification Class I — Serious risk
Date Initiated January 31, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Gilead Sciences, Inc.
Location Foster City, CA
Product Type Drugs
Quantity 3,181 vials

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.

Reason for Recall

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

Distribution Pattern

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

Other Recalls from Gilead Sciences, Inc.

Recall # Classification Product Date
D-0005-2025 Class I Veklury (remdesivir) for injection, 100 mg/vial... Sep 19, 2024
D-0299-2022 Class I Veklury (remdesivir) for injection, 100 mg/vial... Dec 3, 2021
D-0045-2015 Class II Emtriva (emtricitabine) Oral Solution, 10 mg/mL... Oct 1, 2014
D-0013-2015 Class III Truvada (200 mg emtricitabine and 300 mg tenofo... Sep 30, 2014
D-1090-2014 Class III Atripla (efavirenz 600 mg/ emtricitabine 200 mg... Feb 19, 2014

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.