Vancomycin Hydrochloride Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 0409-6533
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Vancomycin Hydrochloride (NDC 0409-6533). A significant event, classified as Class I, was initiated on Dec 22, 2022 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Glass particulate matter detected in injectable."
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: Glass particulate matter detected in injectable.
Dec 22, 2022
Feb 01, 2023
89,700 vials
Recall Profile & Regulatory Data
Event ID
91346
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide and Puerto Rico
Termination Date
Aug 07, 2024
Product Description
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
Batch or Lot Expiration Information
Lot# Lot: 33045BA, EXP 1SEP2023
Affected Packages Involved in this Recall
0409-6531-12Product
0409-6531-02Product
0409-6533-11Product
0409-6533-01Product
0409-6533-21Product
0409-4332-11Product
0409-4332-01Product
0409-3515-11Product
0409-3515-01Product
Class I Terminated
Presence of Particulate Matter: glass particulate found in vial
Aug 30, 2017
Dec 27, 2017
102,500 vials
Recall Profile & Regulatory Data
Event ID
78000
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Nov 08, 2018
Product Description
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
Batch or Lot Expiration Information
Lot# Lot: 632153A; Exp. 03/18
Affected Packages Involved in this Recall
0409-6531-12Product
0409-6531-02Product
0409-6533-11Product
0409-6533-01Product
0409-6533-21Product
0409-4332-11Product
0409-4332-01Product
0409-3515-11Product
0409-3515-01Product
Class III Terminated
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Nov 07, 2014
Nov 26, 2014
316,640 vials
Recall Profile & Regulatory Data
Event ID
69659
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 22, 2017
Product Description
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.
Batch or Lot Expiration Information
Lot# 43-240-DD; Exp. 07/16
Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16
Affected Packages Involved in this Recall
0409-6531-12Product
0409-6531-02Product
0409-6533-11Product
0409-6533-01Product
0409-6533-21Product
0409-4332-11Product
0409-4332-01Product
0409-3515-11Product
0409-3515-01Product
Class II Terminated
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Oct 06, 2014
Feb 25, 2015
90,600 vials
Recall Profile & Regulatory Data
Event ID
69573
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
Termination Date
Dec 15, 2016
Product Description
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.
Batch or Lot Expiration Information
Lot# : 35-315-DD; Exp 1NOV2015
Affected Packages Involved in this Recall
0409-6531-12Product
0409-6531-02Product
0409-6533-11Product
0409-6533-01Product
0409-6533-21Product
0409-4332-11Product
0409-4332-01Product
0409-3515-11Product
0409-3515-01Product
Class II Terminated
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Oct 06, 2014
Feb 25, 2015
200 vials
Recall Profile & Regulatory Data
Event ID
69573
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
Termination Date
Dec 15, 2016
Product Description
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.
Batch or Lot Expiration Information
Lot# One shipment of
Lot# : 34-366-8E02; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
Affected Packages Involved in this Recall
0409-6531-12Product
0409-6531-02Product
0409-6533-11Product
0409-6533-01Product
0409-6533-21Product
0409-4332-11Product
0409-4332-01Product
0409-3515-11Product
0409-3515-01Product
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.
