Bupivacaine Hydrochloride And Epinephrine Injection, Solution
FDA Recall NDC 0409-9043

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 10 recorded enforcement report(s) associated with Bupivacaine Hydrochloride And Epinephrine (NDC 0409-9043). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Hospira, Inc.. The reported reason for this action was: "cGMP deviations: Temperature abuse"

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-1095-2022TERMINATEDD-0626-2021TERMINATEDD-0218-2017ONGOINGD-1216-2015TERMINATEDD-1588-2014TERMINATEDD-1147-2014TERMINATEDD-395-2014TERMINATEDD-66295-001TERMINATEDD-381-2014TERMINATEDD-380-2014TERMINATED

April 2022 Class II Recall: cGMP deviations

Recall Number
D-1095-2022
Class II Terminated
Reason for Recall
cGMP deviations: Temperature abuse
Initiated
Apr 13, 2022
Reported
Jun 15, 2022
Quantity
30 vials

Recall Profile & Regulatory Data

Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

May 2021 Class I Recall: Labeling

Recall Number
D-0626-2021
Class I Terminated
Reason for Recall
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Initiated
May 03, 2021
Reported
Jun 09, 2021
Quantity
163,957 vials

Recall Profile & Regulatory Data

Event ID
87837
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
PFIZER, INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA, Puerto Rico, and Guam
Termination Date
Apr 04, 2023
Product Description
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Batch or Lot Expiration Information
Lot# Lot EG6023, Exp. 07/01/2022
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

August 2016 Class I Recall: Presence of particulate matter

Recall Number
D-0218-2017
Class I Ongoing
Reason for Recall
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Initiated
Aug 04, 2016
Reported
Dec 28, 2016
Quantity
143,250 vials

Recall Profile & Regulatory Data

Event ID
74925
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Hospira Inc., A Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Batch or Lot Expiration Information
Lot# 59064DK, Exp. 11/17
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

April 2015 Class I Recall: Presence of Particulate Matter

Recall Number
D-1216-2015
Class I Terminated
Reason for Recall
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Initiated
Apr 23, 2015
Reported
Jul 15, 2015
Quantity
150,950 Vials

Recall Profile & Regulatory Data

Event ID
71377
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide including Guam.
Termination Date
Jan 26, 2016
Product Description
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Batch or Lot Expiration Information
Lot# : 38-515-DK, Expiry: 1 FEB 2016.
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

September 2014 Class II Recall: Presence of Particulate Matter

Recall Number
D-1588-2014
Class II Terminated
Reason for Recall
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Initiated
Sep 04, 2014
Reported
Sep 24, 2014
Quantity
75,000 vials

Recall Profile & Regulatory Data

Event ID
69247
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 23, 2015
Product Description
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02
Batch or Lot Expiration Information
Lot# LOT 37-268-DK; Exp: 1JAN2016
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

February 2014 Class II Recall: Presence of Particulate Matter

Recall Number
D-1147-2014
Class II Terminated
Reason for Recall
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Initiated
Feb 10, 2014
Reported
Mar 12, 2014
Quantity
115,500 Vials

Recall Profile & Regulatory Data

Event ID
67601
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 01, 2017
Product Description
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02
Batch or Lot Expiration Information
Lot# Lot 25-097-DK; Exp 01/01/2015
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

October 2013 Class II Recall: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

Recall Number
D-395-2014
Class II Terminated
Reason for Recall
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Initiated
Oct 11, 2013
Reported
Jan 08, 2014
Quantity
65109 vials

Recall Profile & Regulatory Data

Event ID
67045
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Termination Date
Nov 10, 2014
Product Description
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Batch or Lot Expiration Information
Lot# 32-484-EV, 32-485-EV Exp: 2/2015.
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

September 2013 Class II Recall: Lack of Assurance of Sterility; potential for vial breakage

Recall Number
D-66295-001
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility; potential for vial breakage
Initiated
Sep 05, 2013
Reported
Oct 16, 2013
Quantity
187,150 vials

Recall Profile & Regulatory Data

Event ID
66295
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Guam and Abu Dhabi
Termination Date
Oct 28, 2014
Product Description
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
Batch or Lot Expiration Information
Lot# Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

July 2013 Class I Recall: Presence of particulate matter

Recall Number
D-381-2014
Class I Terminated
Reason for Recall
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Initiated
Jul 12, 2013
Reported
Dec 25, 2013
Quantity
119,600 vials

Recall Profile & Regulatory Data

Event ID
66260
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 03, 2015
Product Description
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
Batch or Lot Expiration Information
Lot# 23-338-DK, Exp. 11/14
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

July 2013 Class I Recall: Presence of particulate matter

Recall Number
D-380-2014
Class I Terminated
Reason for Recall
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Initiated
Jul 12, 2013
Reported
Dec 25, 2013
Quantity
118,100 vials

Recall Profile & Regulatory Data

Event ID
66260
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 03, 2015
Product Description
0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Batch or Lot Expiration Information
Lot# 18-136-DK; Exp. 6/14
Affected Packages Involved in this Recall
0409-1159-18Product
0409-1159-01Product
0409-1159-19Product
0409-1159-02Product
0409-1160-18Product
0409-1160-01Product
0409-1162-18Product
0409-1162-01Product
0409-1162-19Product
0409-1162-02Product
0409-1163-18Product
0409-1163-01Product
0409-1165-18Product
0409-1165-01Product
0409-1165-19Product
0409-1165-02Product
0409-9043-11Product
0409-9043-01Product
0409-9046-11Product
0409-9046-01Product
0409-9045-11Product
0409-9045-01Product
0409-9045-16Product
0409-9045-17Product
0409-9042-11Product
0409-9042-01Product
0409-9042-16Product
0409-9042-17Product

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.