US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits

      Summary Company Announcement Date: January 30, 2023 FDA Publish Date: … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Hospira Issues a Voluntary Nationwide Recall For 8.4% Sodium Bicarbonate Injection, USP, Neut tm (Sodium Bicarbonate 4% Additive Solution), QUELICIN tm (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due To a Potential For Lack Of Sterility Assurance

Hospira Issues a Voluntary Nationwide Recall For 8.4% Sodium Bicarbonate Injection, USP, Neut tm (Sodium Bicarbonate 4% Additive Solution), QUELICIN tm (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due To a Potential For Lack Of Sterility Assurance

June 16, 2017 By The FDA Leave a Comment

Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

In the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Hospira has not received reports of any adverse events associated

with this issue. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.

Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions.

Sodium bicarbonate is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate.

NeutTM (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.

QuelicinTM (Succinylcholine Chloride Injection, USP) is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation; and Potassium Phosphates Injection, USP 3 mM P/mL (millimoles/mL) is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.i See Appendix for lots and packaging information.

These lots were distributed nationwide in the U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore to wholesalers and hospitals from January to June 2017. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Pfizer is working diligently to restore supply of these products and is in communication with the FDA to address any supply issues.

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

For clinical inquiries, please contact Hospira using the information provided below.

Hospira Contact Contact Information Areas of Support
Pfizer Complaint Management 1-800-438-1985 (24 hours a day 7 days per week) To report adverse events or product complaints
Pfizer Medical Information 1-800-615-0187 (8am to 7pm EST Monday through Friday) Medical inquiries

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.


Appendix: Lots and Packaging Information

8.4% Sodium Bicarbonate Inj., USP

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-6625-02 72109EV 12/01/2018 8.40% 50ml 1X25 VL
72110EV 12/01/2018 8.40% 50ml 1X25 VL
72112EV 12/01/2018 8.40% 50ml 1X25 VL
72113EV 12/01/2018 8.40% 50ml 1X25 VL
72114EV 12/01/2018 8.40% 50ml 1X25 VL
72120EV 12/01/2018 8.40% 50ml 1X25 VL
73068EV 01/01/2019 8.40% 50ml 1X25 VL
73071EV 01/01/2019 8.40% 50ml 1X25 VL
73072EV 01/01/2019 8.40% 50ml 1X25 VL
73224EV 01/01/2019 8.40% 50ml 1X25 VL
73225EV 01/01/2019 8.40% 50ml 1X25 VL
73230EV 01/01/2019 8.40% 50ml 1X25 VL
73231EV 01/01/2019 8.40% 50ml 1X25 VL
73232EV 01/01/2019 8.40% 50ml 1X25 VL
73233EV 01/01/2019 8.40% 50ml 1X25 VL
73234EV 01/01/2019 8.40% 50ml 1X25 VL
73235EV 01/01/2019 8.40% 50ml 1X25 VL
73236EV 01/01/2019 8.40% 50ml 1X25 VL
73298EV 01/01/2019 8.40% 50ml 1X25 VL
74058EV 02/01/2019 8.40% 50ml 1X25 VL
74104EV 02/01/2019 8.40% 50ml 1X25 VL
74105EV 02/01/2019 8.40% 50ml 1X25 VL
74106EV 02/01/2019 8.40% 50ml 1X25 VL
74107EV 02/01/2019 8.40% 50ml 1X25 VL
74197EV 02/01/2019 8.40% 50ml 1X25 VL
74198EV 02/01/2019 8.40% 50ml 1X25 VL
74199EV 02/01/2019 8.40% 50ml 1X25 VL
74200EV 02/01/2019 8.40% 50ml 1X25 VL
74201EV 02/01/2019 8.40% 50ml 1X25 VL
75171EV 03/01/2019 8.40% 50ml 1X25 VL
75172EV 03/01/2019 8.40% 50ml 1X25 VL
75173EV 03/01/2019 8.40% 50ml 1X25 VL
75174EV 03/01/2019 8.40% 50ml 1X25 VL
75175EV 03/01/2019 8.40% 50ml 1X25 VL
75176EV 03/01/2019 8.40% 50ml 1X25 VL
75177EV 03/01/2019 8.40% 50ml 1X25 VL
75178EV 03/01/2019 8.40% 50ml 1X25 VL
75293EV 03/01/2019 8.40% 50ml 1X25 VL
75418EV 03/01/2019 8.40% 50ml 1X25 VL
75419EV 03/01/2019 8.40% 50ml 1X25 VL

Neut™ Sodium Bicarbonate additive solution 4%

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-6609-25 75386EV 03/1/2019 4%/5ML 1X25 FTV NOVA PLUS
0409-6609-02 72226EV 12/01/2018 4%/5ML 1X25 FTV
0409-6609-02 72236EV 12/01/2018 4%/5ML 1X25 FTV
0409-6609-02 75382EV 03/01/2019 4%/5ML 1X25 FTV
0409-6609-02 75383EV 03/01/2019 4%/5ML 1X25 FTV

Succinylcholine Chloride Injection, USP/Quelicin®

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-6629-02 74393EV 05/01/2018 200mg/10ml 1X25 FTV
0409-6629-02 75157EV
75367EV
06/01/2018
06/01/2018
200mg/10ml 1X25 FTV
0409-6629-25 75158EV 06/01/2018 200mg/10ml 1X25 FTV NOVA PLUS
0409-6629-02 75367EV 06/01/2018 200mg/10ml 1X25 FTV

Potassium Phosphates Injection, USP

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-7295-01 74119EV 02/01/2019 45mM 25X15ML
0409-7295-01 74120EV 02/01/2019 45mM 25X15ML
0409-7295-01 74121EV 02/01/2019 45mM 25X15ML
0409-7295-01 74307EV 02/01/2019 45mM 25X15ML
0409-7295-01 74326EV 03/01/2019 45mM 25X15ML
0409-7295-01 74327EV 03/01/2019 45mM 25X15ML
0409-7295-01 75215EV 03/01/2019 45mM 25X15ML

###

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a Reply Cancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits

January 30, 2023 By The FDA

Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone

January 27, 2023 By The FDA

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED

January 26, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Properly Tied Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standards and Burn Hazard

January 25, 2023 By The CPSC

Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging

January 25, 2023 By The FDA

Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz

January 25, 2023 By The FDA

SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products

January 20, 2023 By The FDA

Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard; Sold Exclusively at Williams-Sonoma

January 18, 2023 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products

January 20, 2023 By The FDA

Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard; Sold Exclusively at Williams-Sonoma

January 18, 2023 By The CPSC

Sakar International Recalls Multi-Purpose Helmets Due to Risk of Head Injury

January 18, 2023 By The CPSC

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits
  • Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone
  • Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED
  • Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll
  • ZLINE Expands Recall of Gas Ranges to Include 48-inch Gas Ranges Due to Serious Risk of Injury or Death from Carbon Monoxide Poisoning
  • Properly Tied Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standards and Burn Hazard
  • Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging
  • Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz
  • SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2023 Altrumedia · Terms of Service · Log in