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

Recall Number: D-0352-2019

Firm: Heritage Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20190116

Initiation Date: 20190102

Termination Date: 20210219

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

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