Reported Oct 31, 2018 · Terminated

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd…

Heritage Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Heritage Pharmaceuticals, Inc. · 1 Tower Center Blvd Ste 1700 · East Brunswick, NJ · 08816-1145

Is this the product you have?

  • Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India
  • Mfg forHeritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
Lot codes and dates
    • Lot #: VCIA083
    • Exp. JUN2020
Amount recalled
2,789 Units

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 29, 2023 · Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.