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sodium chloride FDA Alerts

The FDA Alert(s) below may be specifically about sodium chloride or relate to a group or class of drugs which include sodium chloride.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for sodium chloride

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Dec 17, 2018

Audience: Consumer, Health Professional, Pharmacy

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Asclemed USA Inc has not received any reports of adverse events related to this recall.

The products are Dyural-40 convenience kits packaged in plastic trays and Dyural-80 convenience kits packaged in plastic trays, containing Sodium Chloride, USP, 0.9% by Fresenius Kabi.

The affected Dyural-40 lots include the following:

LOTEXPLOTEXPLOTEXPLOTEXP
051518X51/31/2019072518X35/31/2019090518X46/30/2019092418X18/31/2019
051618X11/31/2019072718X15/31/2019091818X21/31/2019092818X48/31/2019
052318X45/1/2019080318X25/31/2019091818X37/31/2019101018X38/31/2019
052318X55/31/2019082318X46/30/2019091818X46/30/2019101018X58/31/2019
062818X15/31/2019083118X16/30/2019091818X58/31/2019102418X59/30/2019

The affected Dyural-80 lots include the following:

LOTEXPLOTEXPLOTEXPLOTEXP
050918X112/31/2018062718X16/30/2019080718X76/30/2019100518X67/31/2019
051518X45/31/2019062718X26/30/2019080918X36/30/2019101118X37/31/2019
051618X1012/31/2018062818X36/30/2019083018X26/30/2019101518X27/31/2019
051818X412/31/2018062818X46/30/2019083118X26/30/2019101618X77/31/2019
051818X55/31/2019070918X16/30/2019083118X56/30/2019101618X87/31/2019
052118X45/31/2019071018X56/30/2019090518X56/30/2019101818X37/31/2019
052118X55/31/2019071118X46/30/2019090518X67/31/2019101918X17/31/2019
052918X75/31/2019071118X56/30/2019090718X27/31/2019102318X17/31/2019
061118X85/1/2019071718X22/28/2019090718X37/31/2019103118X17/31/2019
061118X95/31/2019072018X66/30/2019090718X57/31/2019103118X27/31/2019
061118X105/31/2019072418X36/30/2019091118X77/31/2019103118X39/30/2019
061418X25/31/2019072418X46/30/2019091318X57/31/2019110618X19/30/2019
061518X15/31/2019072518X26/30/2019091918X17/31/2019110818X19/30/2019
061518X26/30/2019073018X46/30/2019092718X17/31/2019
061918X26/30/2019073018X86/30/2019092718X27/31/2019
062518X26/30/2019080218X36/30/2019092818X37/31/2019

The products can be identified by lot and expiration stamped on the front of each convenience kit. Product was distributed Nationwide to distributors and physicians.

Asclemed USA Inc is notifying its distributors and customers by email and is arranging for return of all recalled products. Distributors and physicians that have Dyural-40 or Dyural-80 which is being recalled should stop using them and return to place of purchase.

Consumers with questions regarding this recall can contact Asclemed USA Inc by calling (310) 320-0100 ext. 120 Monday through Friday from 7:30am to 4:00pm PST or emailing christinah@enovachem.us.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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

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

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Nov 20, 2018

Audience: Consumer, Health Professional, Pharmacy

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.

For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Fresenius Kabi USA has not received any reports of adverse events related to this recall. 

Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. It is also indicated for use in flushing of intravenous catheters. The product is packaged as Sodium Chloride Injection, USP 0.9%, 10mL fill in a 10mL vial; Sodium Chloride Injection, USP 0.9% 20mL fill in a 20mL vial; both size vials are packaged in a 25-unit tray. See the tables below for a full list of the affected lots including lot numbers and expiration dates.

Fresenius Kabi USA is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped, the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.

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

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

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

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.

Product Name /Product sizeUnit of Sale NDC NumberUnit of Use NDC NumberProduct CodeBatch NumberExpiration Date
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601311211/2018
601311311/2018
601311411/2018
601318011/2018
601318111/2018
601318211/2018
601323701/2019
601323801/2019
601323901/2019
601346802/2019
601351202/2019
601351302/2019
601355102/2019
601355202/2019
601355302/2019
601360702/2019
601360802/2019
601361002/2019
601362703/2019
601367803/2019
601367903/2019
601382203/2019
601382303/2019
601382403/2019
601392404/2019
601392504/2019
601392604/2019
601400305/2019
601400405/2019
601400505/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601426005/2019
601430105/2019
601430205/2019
601430306/2019
601430406/2019
601430506/2019
601430606/2019
601430706/2019
601438406/2019
601440406/2019
601440506/2019
601445306/2019
601445406/2019
601445506/2019
601447906/2019
601455707/2019
601455807/2019
601460607/2019
601464908/2019
601465008/2019
601470408/2019
601476608/2019
601476708/2019
601476808/2019
601484108/2019
601484208/2019
601484308/2019
601486108/2019
601486208/2019
601486308/2019
601504909/2019
601505009/2019
601508809/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601511810/2019
601512710/2019
601512810/2019
601518610/2019
601518710/2019
601518810/2019
601523310/2019
601523410/2019
601523510/2019
601528511/2019
601528611/2019
601528711/2019
601540811/2019
601540911/2019
601541011/2019
601545211/2019
601545311/2019
601545411/2019
601557211/2019
601557312/2019
601557412/2019
601561612/2019
601561712/2019
601561812/2019
601592201/2020
601592301/2020
601592401/2020
601600202/2020
601600302/2020
601600402/2020
601607702/2020
601610402/2020
601620802/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601620902/2020
601621002/2020
601625802/2020
601625902/2020
601626002/2020
601626102/2020
601626203/2020
601626303/2020
601626403/2020
601632303/2020
601632403/2020
601632503/2020
601638303/2020
601638403/2020
601638503/2020
601638603/2020
601638703/2020
601638803/2020
601638903/2020
601658404/2020
601658504/2020
601662104/2020
601662204/2020
601662304/2020
601676505/2020
601676605/2020
601676705/2020
601676805/2020
601676905/2020
601687506/2020
601687606/2020
601687706/2020
601687806/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial63323-186-1063323-186-01918610601687906/2020
601728806/2020
601728906/2020
601729006/2020
601729106/2020
601738207/2020
601742507/2020
601742607/2020
601742707/2020
601742807/2020
601742907/2020
601747007/2020
601747107/2020
601747207/2020
601747307/2020
601747407/2020
601767508/2020
601772508/2020
601772608/2020
Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial63323-186-2063323-186-03918620601306211/2018
601416205/2019
601416305/2019
601416405/2019
601437706/2019
601437806/2019
601437906/2019
601600502/2020
601607102/2020
601607202/2020
601607302/2020
601738307/2020
601738407/2020
601742207/2020
601742307/2020
601742407/2020

 

 

0.9 Percent Sodium Chloride Injection by ICU Medical: Recall - Presence of Particulate Matter

Jul 31, 2017

Audience: Pharmacy

[Posted 07/31/2017]

ISSUE: ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.

Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.

BACKGROUND: 0.9% Sodium Chloride Injection, USP 1000 mL is an intravenous solution indicated for parenteral replenishment of fluid. The affected product lot was manufactured in the U.S. by Hospira, a Pfizer company, on February 1, 2016 and was distributed nationwide to Hospira customers between April 14, 2016 and February 2, 2017. The affected lot is: NDC 0409-7983-09, Lot # 61-841-FW Expires January 01, 2018 - 1000mL Single Dose Flexible Container.

RECOMMENDATION: Prior to administration, healthcare professionals, as instructed in the product labeling, should visually examine the product for particulate matter and discoloration and should discard if a defect is identified.

ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products. Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase.  Customers with questions regarding this recall can call ICU Medical at 1-800-441-4100 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[07/28/2017 - Press Release - ICU Medical, Inc.]

Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

Jan 5, 2016

Audience: Pharmacy

Includes:

  • 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container
  • 70% Dextrose Injection (2000 mL) USP

ISSUE: Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.

The lots being recalled were distributed to customers and distributors in the United States between June 6, 2015 and December 16, 2015. See the Press Release for affected lot numbers.

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

BACKGROUND: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container is intended for IV use as a source of water and electrolytes and may also be used as a priming solution in hemodialysis procedures. 70% Dextrose Injection (2000 mL) USP is indicated as a source of calories and water for hydration.

RECOMMENDATION: Baxter is directing customers not to use the product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7 a.m. and 6 p.m., Central Time. Unaffected lots of product are available for replacement. This recall is not expected to affect current supply and product remains available for current customers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[12/18/2015 - Press Release - Baxter]

0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port

Jul 31, 2015

Audience: Pharmacy, Risk Manager

ISSUE:  Baxter International Inc. announced a voluntarily recall of one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

BACKGROUND: The lot being recalled was distributed to customers and distributors nationwide between January 22, 2015 and February 12, 2015. This recall affects the following lot Number: C964601, NDC: 0338-0049-03; Expiration Date: 04/30/2016 

RECOMMENDATION: Customers were notified via letter that they should not use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[07/30/2015 - Press Release - Baxter International Inc]
 

0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter

Jul 19, 2015

Audience: Risk Manager, Pharmacy, Nursing

ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.
 

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
 

This recall affects Lot Numbers P319921 and P327635.

BACKGROUND: The lots being recalled were distributed to customers and distributors in the United States between October 7, 2014 and July 14, 2015.

RECOMMENDATION: Baxter is directing customers not to use product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[07/17/2015 - Press Release - Baxter]

Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter

Apr 10, 2015

Audience: Pharmacy, Risk Manager, Nursing

[Posted 04/10/2015]

ISSUE:  Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.

BACKGROUND: The lots being recalled were distributed to customers and distributors in the United States and Bermuda between January 14, 2015 and March 5, 2015. See the press release for a listing of affected products.

While Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter. Baxter began the customer notification process on March 24, 2015.

RECOMMENDATION: Customers have been directed not to use products from the recalled lots. Recalled products should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[04/09/2015 - Press Release -  Baxter]

IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients

Apr 8, 2015

Audience: Risk Manager, Health Professionals, Pharmacy

UPDATED 04/08/2015. FDA’s laboratory analysis of Wallcur’s simulated Practi-0.9% sodium chloride IV is now complete. FDA sampled 11 of Wallcur’s simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples.

These include bacteria (e.g., Bacillus spp., Brevundimonas sp., Pseudomonas spp., Rhizobium radiobacter, Sphingomonas koreensis, Sphingomonas trueperi, Sphingobium sp.). It is possible that additional bacteria are present in other bags that were not included in this analysis.

FDA is aware of more than 40 individuals who received infusions of the simulated Practi-0.9% sodium chloride IV products; 26 of whom reported adverse events that ranged from flu-like symptoms to sepsis, a potentially life-threatening complication of an infection.  Of those 26 individuals, 2 deaths and 11 hospitalizations were reported.

FDA is reiterating its previous recommendations that ask health care professionals and consumers to do the following:

  • Visually inspect all current IV solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-0.9% sodium chloride,” or “For clinical training purposes only”;
  • Consider reviewing clinic procedures and make sure there are procedures in place to visually inspect all future shipments of IV products to ensure they are appropriate for patient use;
  • Seek medical attention if you were given a simulated Practi-0.9% sodium chloride product and you experience the symptoms described above;
  • Report any suspected adverse events associated with accidental or intentional exposure to simulated products to FDA’s MedWatch program online or at 1-800-332-1088.

FDA has been working closely with Wallcur to make changes to its labeling and distribution practices to prevent future occurrences.  FDA also has been working with the simulation medical products industry to highlight the risks associated with the incorrect use of these products.

 

UPDATED 01/10/2015.  Wallcur’s Practi-IV solutions bags are recalled.

AUDIENCE: Risk Manager, Health Professionals, Pharmacy

ISSUE: The U.S. Food and Drug Administration is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. These products are for training purposes only. There have been reports of serious adverse events associated with the use of certain of these products – i.e., Practi IV Solution Bags.

BACKGROUND: FDA has become aware that some Wallcur training IV products have been distributed to health care facilities and administered to patients. FDA will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform health care professionals and state health departments.

RECOMMENDATION: Before administering IV solutions to patients, health care providers should carefully check the labels to ensure that the products are not training products, such as Practi IV Solution Bags marketed by Wallcur. Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.

If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to FDA’s MedWatch Adverse Event Reporting program by:

 
[01/10/2015 - Press Release - Wallcur]

[12/30/2014 - CDER Statement- FDA]

0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter

Mar 6, 2015

Audience: Pharmacy, Risk Manager

ISSUE: Hospira announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects (IV only) and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

BACKGROUND: This lot was distributed nationwide from December 2014 through January 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the consumer 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 1-888-714-5079 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[03/05/2015 - Press Release - Hospira]

0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter

Jan 23, 2015

Audience: Pharmacy, Risk Manager

[Posted 01/23/2015]

ISSUE: Hospira, Inc. announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

BACKGROUND: The affected lot was distributed nationwide from September 2014 through November 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the consumer level. Hospira has notified 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 1-877-877-0164 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. Hospira will provide allocation credits and make replacement product available for contracted customers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[01/20/2015 - Press Release - Hospira, Inc]

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

Dec 16, 2014

Audience: Risk Manager, Pharmacy, Nursing

ISSUE: Baxter International Inc. initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter. The issue was identified upon standard visual inspection prior to patient administration.

This recall affects lot numbers P317842 and P317891.
 
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and the patient's underlying medical condition. In the absence of in-line filtration, particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization (blockage of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver).

BACKGROUND: 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose powdered drug.

RECOMMENDATION: According to the 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container product labeling, the product should be inspected visually for particulate matter and discoloration whenever solution and container permit.

Baxter has notified customers, who are being directed not to use product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[12/11/2014 - Press Release - Baxter International Inc.]

Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter

Apr 26, 2013

Audience: Pharmacy, Patient, Health Professional

ISSUE: Hospira notified the public that last August it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The four single particles were identified as follows: polyester fiber, nylon fiber, cotton fiber and nitrocellulose fiber, respectively. Hospira is investigating to determine the root cause.

Affected lot number is 05-201-JT (the lot number may be followed by a -01). The affected product has an expiration date of May 1, 2013, and was distributed within the United States between May 2011 and August 2011 to wholesalers/distributors, hospitals and pharmacies.

If solution containing particulate matter is used on a patient, this may result acutely in local inflammation, phlebitis, and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body. Chronically, following sequestration, granulomatous formation in the lungs is possible.

BACKGROUND: This product is used as a source of water and electrolytes. Product was distributed within the following U.S. states: Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-597-9582 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[04/25/2013 - Press Release - Hospira]

Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates

Apr 1, 2013

Audience: Risk Manager, Pharmacy

ISSUE: Hospira, Inc. notified healthcare professional of a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL, Flexible Container, NDC 0409-7983-09. This action is due to one confirmed customer report where brass particulate was identified in the primary container in the form of several small grey/brown particles. The affected lot number is 25-037-JT (the lot number may be followed by a -01 or -90), with an expiration date of January 1, 2015. Hospira is investigating to determine the root cause.

The brass particulate was identified as containing copper, zinc and lead. If administered, solution containing brass particulate may result in occlusion of small blood vessels. In a worst-case scenario, copper toxicity may potentially result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal.

BACKGROUND: The product is used as a source of water and electrolytes and is packaged in a 1000 mL flexible container. The affected lot was distributed nationwide between January 2013 and March 2013 to wholesalers/distributors, hospitals and pharmacies.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-480-2853 between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[03/29/2013 - Press Release - Hospira, Inc]

American Regent Injectable Products: Recall - Visible Particulates in Products

Jun 7, 2011

Audience: Pharmacy

  • Methyldopate HCL Injection, USP 5ml Single Dose Vial
  • Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial
  • Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
  • Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
  • Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages
  • Sodium Thiosulfate Injection USP 10%
  • Potassium Phosphates Injection, USP

 

[UPDATED 06/07/2011] Methyldopate HCL Injection, USP 5ml Single Dose Vial recalled.

[UPDATED 05/06/2011] Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial recalled.

[UPDATED 04/27/2011] Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial recalled.

[UPDATED 03/18/2011]  Dexamethasone Sodium Phosphate Injection products recalled.

[UPDATED 03/17/2011] Concentrated Sodium Chloride Injection products recalled.

[Posted 02/05/2011]

ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[06/06/2011 - Press Release, Methyldopate HCL Injection - American Regent]
[05/05/2011 - Press Release, Caffeine & Sodium Benzoate Injection - American Regent]
[04/26/2011 - Press Release, Ammonium Molybdate Injection - American Regent]
[03/16/2011 - Press Release, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release, Bacteriostatic Sodium Chloride - American Regent] 
[03/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent] 
[02/04/2011 - Press Release, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release, Potassium Phosphates - American Regent]   

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection]
[12/29/2010 - Sodium Bicarbonate Injection]

Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility

Oct 15, 2010

Audience: Risk Manager

ISSUE: Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.

BACKGROUND: The Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringes are intended for the flushing of venous access devices and IV tubing.

RECOMMENDATION: Consumers who have 5ml fill in 6 cc saline pre-filled syringes manufactured by Excelsior Medical should immediately discontinue using these syringes and return them to the point of purchase.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[10/15/2010 - Press Release - Excelsior Medical]
 

    

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