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Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Phar...

FDA Recall #D-0094-2019 — Class II — October 15, 2018

Recall #D-0094-2019 Date: October 15, 2018 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Heritage Pharmaceuticals, Inc. — East Brunswick, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,789 Units

Distribution

Nationwide within the United States

Code Information

Lot #: VCIA083, Exp. JUN2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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