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FDAOctober 15, 2018drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

heritage pharmaceuticalsheritage

UPCs

323155216388

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 Details · AllClear