Daptomycin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 67457-813
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 Daptomycin (NDC 67457-813). A significant event, classified as Class I, was initiated on Jul 07, 2020 by Mylan Institutional Llc. The reported reason for this action was: "Presence of Particulate Matter"
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 I Terminated
Presence of Particulate Matter
Jul 07, 2020
Aug 12, 2020
18,480 vials
Recall Profile & Regulatory Data
Event ID
85956
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Mylan Institutional LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jan 27, 2023
Product Description
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50
Batch or Lot Expiration Information
Lot# : 7605112, Exp 10/2021
Affected Packages Involved in this Recall
67457-813-50Product
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.
