Reported Jan 16, 2019 · Terminated

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals 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 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only
  • Mfd byEmcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg
  • forHeritage Pharmaceuticals Inc. NDC 23155-0216-31
Lot codes and dates
    • Lot #: VCIA082
    • Exp. MAY 2020
    • VCIA083
    • VCIA084
    • Exp. JUNE 2020
Amount recalled
5,060 units

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: complaints received about dried powder on the outside of 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 Feb 19, 2021 · Data as of Sep 19, 7:54 PM UTC

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