FDAClass IIOctober 31, 2018

Cidofovir injection 375 mg/mL recall: Sterility Concern

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…

Why was Cidofovir injection 375 mg/mL recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: VCIA083, Exp. JUN2020

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…
Recalling firm
Heritage Pharmaceuticals, Inc.
Quantity
2,789 Units
Distribution
Nationwide within the United States
Recall date
October 31, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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