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Heritage Pharmaceuticals, Inc. recalls Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawad

Recalled October 31, 2018 · FDA recall D-0094-2019 · Heritage Pharmaceuticals

Hazard
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle · FDA Class II
Units
2,789 Units
Sold at
Nationwide within the United States

Description

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

Product
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
Manufacturer(s)
Heritage Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov