Cefepime Hydrochloride And Dextrose Injection, Solution
FDA Recall NDC 0264-3193
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Cefepime Hydrochloride And Dextrose (NDC 0264-3193). A significant event, classified as Class I, was initiated on Nov 21, 2013 by B. Braun Medical Inc.. The reported reason for this action was: "Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units."
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: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Nov 21, 2013
May 07, 2014
22,248 units
Recall Profile & Regulatory Data
Event ID
66913
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Spain
Termination Date
Dec 04, 2014
Product Description
Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11
Batch or Lot Expiration Information
Lot# H2L712, Exp 09/14
Affected Packages Involved in this Recall
0264-3193-11Product
0264-3195-11Product
Class I Terminated
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Oct 15, 2013
Feb 12, 2014
18,936 Containers
Recall Profile & Regulatory Data
Event ID
66497
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 04, 2014
Product Description
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
Batch or Lot Expiration Information
Lot# Lot H3A744, Exp 01/15
Affected Packages Involved in this Recall
0264-3193-11Product
0264-3195-11Product
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.
