Key Takeaway
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31 by Heritage Pharmaceuticals, Inc. was recalled on January 2, 2019. The hazard: Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
Description
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
Hazard / Reason
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
DrugsCompany Information
Heritage Pharmaceuticals, Inc.
Eatontown, NJ, United States
View all 22 recalls by Heritage Pharmaceuticals, Inc. →Distribution
Nationwide
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.