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Hyper-Sal FDA Alerts

The FDA Alert(s) below may be specifically about Hyper-Sal or relate to a group or class of drugs which include Hyper-Sal (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:

LOT EXP LOT EXP LOT EXP LOT EXP
051518X5 1/31/2019 072518X3 5/31/2019 090518X4 6/30/2019 092418X1 8/31/2019
051618X1 1/31/2019 072718X1 5/31/2019 091818X2 1/31/2019 092818X4 8/31/2019
052318X4 5/1/2019 080318X2 5/31/2019 091818X3 7/31/2019 101018X3 8/31/2019
052318X5 5/31/2019 082318X4 6/30/2019 091818X4 6/30/2019 101018X5 8/31/2019
062818X1 5/31/2019 083118X1 6/30/2019 091818X5 8/31/2019 102418X5 9/30/2019

The affected Dyural-80 lots include the following:

LOT EXP LOT EXP LOT EXP LOT EXP
050918X1 12/31/2018 062718X1 6/30/2019 080718X7 6/30/2019 100518X6 7/31/2019
051518X4 5/31/2019 062718X2 6/30/2019 080918X3 6/30/2019 101118X3 7/31/2019
051618X10 12/31/2018 062818X3 6/30/2019 083018X2 6/30/2019 101518X2 7/31/2019
051818X4 12/31/2018 062818X4 6/30/2019 083118X2 6/30/2019 101618X7 7/31/2019
051818X5 5/31/2019 070918X1 6/30/2019 083118X5 6/30/2019 101618X8 7/31/2019
052118X4 5/31/2019 071018X5 6/30/2019 090518X5 6/30/2019 101818X3 7/31/2019
052118X5 5/31/2019 071118X4 6/30/2019 090518X6 7/31/2019 101918X1 7/31/2019
052918X7 5/31/2019 071118X5 6/30/2019 090718X2 7/31/2019 102318X1 7/31/2019
061118X8 5/1/2019 071718X2 2/28/2019 090718X3 7/31/2019 103118X1 7/31/2019
061118X9 5/31/2019 072018X6 6/30/2019 090718X5 7/31/2019 103118X2 7/31/2019
061118X10 5/31/2019 072418X3 6/30/2019 091118X7 7/31/2019 103118X3 9/30/2019
061418X2 5/31/2019 072418X4 6/30/2019 091318X5 7/31/2019 110618X1 9/30/2019
061518X1 5/31/2019 072518X2 6/30/2019 091918X1 7/31/2019 110818X1 9/30/2019
061518X2 6/30/2019 073018X4 6/30/2019 092718X1 7/31/2019
061918X2 6/30/2019 073018X8 6/30/2019 092718X2 7/31/2019
062518X2 6/30/2019 080218X3 6/30/2019 092818X3 7/31/2019

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 size Unit of Sale NDC Number Unit of Use NDC Number Product Code Batch Number Expiration Date
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6013112 11/2018
6013113 11/2018
6013114 11/2018
6013180 11/2018
6013181 11/2018
6013182 11/2018
6013237 01/2019
6013238 01/2019
6013239 01/2019
6013468 02/2019
6013512 02/2019
6013513 02/2019
6013551 02/2019
6013552 02/2019
6013553 02/2019
6013607 02/2019
6013608 02/2019
6013610 02/2019
6013627 03/2019
6013678 03/2019
6013679 03/2019
6013822 03/2019
6013823 03/2019
6013824 03/2019
6013924 04/2019
6013925 04/2019
6013926 04/2019
6014003 05/2019
6014004 05/2019
6014005 05/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6014260 05/2019
6014301 05/2019
6014302 05/2019
6014303 06/2019
6014304 06/2019
6014305 06/2019
6014306 06/2019
6014307 06/2019
6014384 06/2019
6014404 06/2019
6014405 06/2019
6014453 06/2019
6014454 06/2019
6014455 06/2019
6014479 06/2019
6014557 07/2019
6014558 07/2019
6014606 07/2019
6014649 08/2019
6014650 08/2019
6014704 08/2019
6014766 08/2019
6014767 08/2019
6014768 08/2019
6014841 08/2019
6014842 08/2019
6014843 08/2019
6014861 08/2019
6014862 08/2019
6014863 08/2019
6015049 09/2019
6015050 09/2019
6015088 09/2019
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6015118 10/2019
6015127 10/2019
6015128 10/2019
6015186 10/2019
6015187 10/2019
6015188 10/2019
6015233 10/2019
6015234 10/2019
6015235 10/2019
6015285 11/2019
6015286 11/2019
6015287 11/2019
6015408 11/2019
6015409 11/2019
6015410 11/2019
6015452 11/2019
6015453 11/2019
6015454 11/2019
6015572 11/2019
6015573 12/2019
6015574 12/2019
6015616 12/2019
6015617 12/2019
6015618 12/2019
6015922 01/2020
6015923 01/2020
6015924 01/2020
6016002 02/2020
6016003 02/2020
6016004 02/2020
6016077 02/2020
6016104 02/2020
6016208 02/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6016209 02/2020
6016210 02/2020
6016258 02/2020
6016259 02/2020
6016260 02/2020
6016261 02/2020
6016262 03/2020
6016263 03/2020
6016264 03/2020
6016323 03/2020
6016324 03/2020
6016325 03/2020
6016383 03/2020
6016384 03/2020
6016385 03/2020
6016386 03/2020
6016387 03/2020
6016388 03/2020
6016389 03/2020
6016584 04/2020
6016585 04/2020
6016621 04/2020
6016622 04/2020
6016623 04/2020
6016765 05/2020
6016766 05/2020
6016767 05/2020
6016768 05/2020
6016769 05/2020
6016875 06/2020
6016876 06/2020
6016877 06/2020
6016878 06/2020
Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial 63323-186-10 63323-186-01 918610 6016879 06/2020
6017288 06/2020
6017289 06/2020
6017290 06/2020
6017291 06/2020
6017382 07/2020
6017425 07/2020
6017426 07/2020
6017427 07/2020
6017428 07/2020
6017429 07/2020
6017470 07/2020
6017471 07/2020
6017472 07/2020
6017473 07/2020
6017474 07/2020
6017675 08/2020
6017725 08/2020
6017726 08/2020
Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial 63323-186-20 63323-186-03 918620 6013062 11/2018
6014162 05/2019
6014163 05/2019
6014164 05/2019
6014377 06/2019
6014378 06/2019
6014379 06/2019
6016005 02/2020
6016071 02/2020
6016072 02/2020
6016073 02/2020
6017383 07/2020
6017384 07/2020
6017422 07/2020
6017423 07/2020
6017424 07/2020

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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