Levophed Injection, Solution, Concentrate
FDA Recall NDC 0409-3375
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 Levophed (NDC 0409-3375). A significant event, classified as Class II, was initiated on Aug 22, 2017 by Hospira, Inc.. The reported reason for this action was: "Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process."
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 sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Aug 22, 2017
Sep 27, 2017
98,050 vials
Recall Profile & Regulatory Data
Event ID
77956
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States Nationwide (including Puerto Rico) and Singapore
Termination Date
Feb 19, 2023
Product Description
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
Batch or Lot Expiration Information
Lot# : 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18
Affected Packages Involved in this Recall
0409-3375-14Product
0409-3375-04Product
0409-1443-14Product
0409-1443-04Product
May 2017 Class II Recall: GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Recall Number
Class II Terminated
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
May 18, 2017
Jun 21, 2017
(720503A): 43,200 vials, (720603A): 400 vials
Recall Profile & Regulatory Data
Event ID
77288
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc., A Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Canada and Singapore
Termination Date
May 02, 2019
Product Description
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
Batch or Lot Expiration Information
Lot# 720503A, 720603A (Canada only)
Affected Packages Involved in this Recall
0409-3375-14Product
0409-3375-04Product
0409-1443-14Product
0409-1443-04Product
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.
