Cidofovir Injection 375mg/ vial injection recalled over sterility concerns
- Recall date
- January 2, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Heritage Pharmaceuticals, Inc. recalls Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinja…
- Recall number
- D-0352-2019
- FDA classification
- Class II
- Brand / firm
- Heritage Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
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