FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Heritage Pharmaceuticals Cidofovir injection 375 mg/mL Recall

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

Heritage Pharmaceuticals, Inc. · East Brunswick, NJ

Risk level
Class II
Reported by FDA
Oct 31, 2018
Recall ID
D-0094-2019
Check your lot numberHow we source this data

Summary

Heritage Pharmaceuticals recalled Cidofovir injection 375 mg/mL starting Oct 15, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0094-2019 on Oct 31, 2018. Reason: Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot #: VCIA083, Exp. JUN2020

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0094-2019
Classification
Class II
Status
Terminated
Recall initiated
Oct 15, 2018
FDA report date
Oct 31, 2018
Quantity
2,789 Units
Recall type
Voluntary: Firm initiated
Recalling firm
Heritage Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0094-2019, exactly as published.

Show all FDA fields
City
East Brunswick
State
NJ
Status
Terminated
Country
United States
Event ID
81276
Address
1 Tower Center Blvd Ste 1700
Code information
Lot #: VCIA083, Exp. JUN2020
Postal code
08816-1145
Report date
Oct 31, 2018
Product type
Drugs
Recall number
D-0094-2019
Classification
Class II
Recalling firm
Heritage Pharmaceuticals, Inc.
Product quantity
2,789 Units
Termination date
Mar 29, 2023
Reason for recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide within the United States
Recall initiation date
Oct 15, 2018
Initial firm notification
Letter
Center classification date
Oct 24, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0094-2019, published Oct 31, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls