FDA-Drug2018-10-31Class II

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

Heritage Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide within the United States
Affected count
2,789 Units
Manufactured in
1 Tower Center Blvd Ste 1700, N/A, East Brunswick, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2019

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