Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31

Recall Number: D-0094-2019

Firm: Heritage Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20181031

Initiation Date: 20181015

Termination Date: 20230329

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

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31