FDAFDA · Food and drugs·Recall number D-0352-2019
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
Published January 16, 2019 · Recall initiated: January 2, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Distributor
- Nationwide
- Lot
- Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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