Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection Recalled by Heritage Pharmaceuticals, Inc. Due to Lack of Assurance of Sterility: complaints received about...

Date: October 15, 2018
Company: Heritage Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Heritage Pharmaceuticals, Inc. directly.

Affected 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

Quantity: 2,789 Units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Heritage Pharmaceuticals, Inc.

Heritage Pharmaceuticals, Inc. has 13 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report