Propofol Injection, Emulsion
FDA Recall NDC 0409-4699
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 15 recorded enforcement report(s) associated with Propofol (NDC 0409-4699). A significant event, classified as Class I, was initiated on Aug 22, 2022 by Hospira, Inc.. 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
D-1540-2022D-1301-2022D-0381-2015D-0389-2015D-1547-2014D-1033-2014D-66637-001D-932-2013D-887-2013D-297-2013D-223-2013D-159-2013D-1685-2012D-1672-2012D-1382-2012
Class I Terminated
Presence of particulate matter
Aug 22, 2022
Sep 21, 2022
5,390 vials
Recall Profile & Regulatory Data
Event ID
90785
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jun 30, 2025
Product Description
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Batch or Lot Expiration Information
Lot# : EA7470, Exp 6/1/2023
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class I Terminated
Presence of particulate matter: particulate identified as a beetle.
Jul 13, 2022
Aug 03, 2022
54,000 vials
Recall Profile & Regulatory Data
Event ID
90581
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
May 13, 2024
Product Description
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Batch or Lot Expiration Information
Lot# : DX9067, Exp 5/1/2023
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Dec 23, 2014
Feb 04, 2015
126,075 vials
Recall Profile & Regulatory Data
Event ID
70179
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 30, 2015
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
Batch or Lot Expiration Information
Lot# Lot 35-844-DJ, Exp 11/01/2015
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class I Terminated
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Oct 06, 2014
Feb 25, 2015
2,500 vials
Recall Profile & Regulatory Data
Event ID
69573
Classification
Class I
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
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Batch or Lot Expiration Information
Lot# One shipment of
Lot# : 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class I Terminated
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Apr 02, 2014
Aug 27, 2014
844,300 vials
Recall Profile & Regulatory Data
Event ID
67936
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 29, 2015
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
Batch or Lot Expiration Information
Lot# s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Dec 12, 2013
Jan 29, 2014
126,425 vials
Recall Profile & Regulatory Data
Event ID
67322
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 16, 2014
Product Description
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Batch or Lot Expiration Information
Lot# : 27-568-DJ*, Exp 03/15, Note * may be followed by 01
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Oct 11, 2013
Nov 13, 2013
70,450 vials
Recall Profile & Regulatory Data
Event ID
66637
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 28, 2014
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Batch or Lot Expiration Information
Lot# : 27-570-DJ, Exp 03/01/15
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Aug 14, 2013
Sep 18, 2013
283,150 vials
Recall Profile & Regulatory Data
Event ID
66134
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 18, 2014
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
Batch or Lot Expiration Information
Lot# : 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
May 2013 Class II Recall: Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Recall Number
Class II Terminated
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
May 25, 2013
Aug 21, 2013
94,110 vials
Recall Profile & Regulatory Data
Event ID
65616
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 18, 2014
Product Description
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
Batch or Lot Expiration Information
Lot# Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Apr 08, 2013
May 01, 2013
245,250 vials
Recall Profile & Regulatory Data
Event ID
64990
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 03, 2014
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Batch or Lot Expiration Information
Lot# : 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Feb 25, 2013
Apr 03, 2013
68,020 vials
Recall Profile & Regulatory Data
Event ID
64719
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 08, 2014
Product Description
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.
Batch or Lot Expiration Information
Lot# a)
Lot# : 06-804-DJ*, Exp 1JUN2013; and b)
Lot# : 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Nov 15, 2012
Feb 20, 2013
273,925 vials
Recall Profile & Regulatory Data
Event ID
64062
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 27, 2014
Product Description
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Batch or Lot Expiration Information
Lot# : a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number may be followed by 01.
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Aug 29, 2012
Oct 03, 2012
148,630 vials
Recall Profile & Regulatory Data
Event ID
63198
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 08, 2013
Product Description
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Batch or Lot Expiration Information
Lot# Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Aug 03, 2012
Sep 05, 2012
56,420 vials
Recall Profile & Regulatory Data
Event ID
62999
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 06, 2014
Product Description
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
Batch or Lot Expiration Information
Lot# 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
Class II Terminated
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Apr 11, 2012
Jun 20, 2012
a) 36,125 vials; b) 31,280 vials
Recall Profile & Regulatory Data
Event ID
62009
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jun 27, 2013
Product Description
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
Batch or Lot Expiration Information
Lot# : a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Affected Packages Involved in this Recall
0409-4699-50Product
0409-4699-30Product
0409-4699-53Product
0409-4699-33Product
0409-4699-54Product
0409-4699-24Product
0409-6010-02Product
0409-6010-25Product
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.
