Cidofovir Dihydrate Injection, Solution
FDA Recall NDC 23155-216
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cidofovir Dihydrate (NDC 23155-216). A significant event, classified as Class II, was initiated on Oct 15, 2018 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Oct 15, 2018
Oct 31, 2018
2,789 Units
Recall Profile & Regulatory Data
Event ID
81276
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Heritage Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 29, 2023
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
Batch or Lot Expiration Information
Lot# : VCIA083, Exp. JUN2020
Affected Packages Involved in this Recall
23155-216-31Product
3231552163Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
