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Hospira, Inc., has announced a US-wide, user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container (NDC 0409-7929-09, Lot 35-118-JT).
The company confirmed a report of particulate within the solution of the primary container. It was a filamentous-like structured particulate indicative of mold.
An analysis of the primary container and overwrap revealed a puncture that had caused the container to leak.
Intravenous administration of a non-sterile product can result in infections that may be life-threatening and could result in prolonged hospitalization or organ failure.
However, Hospira has not received reports of any adverse events associated with this issue for this lot and has not identified any quality issues with retention samples for this lot.
Lactated Ringers and 5% Dextrose Injection is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container.
This lot (35-118-JT) was distributed nationwide—from December 2013 through February 2014—to hospitals, clinics, wholesalers, and distributors.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 (8am to 5pm EST, Monday through Friday) to arrange for the return of the product.
For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187 (available 24 hours a day, 7 days per week) or [email protected].
To report adverse events or product complaints, contact Hospira Global
Complaint Management at 1-800-441-4100 (8am to 5pm CT, Monday through Friday) or
Adverse events or quality problems can also be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program. 
Image courtesy of Hospira
Hospira, Inc., has announced a US-wide, user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container (NDC 0409-7929-09, Lot 35-118-JT).
The company confirmed a report of particulate within the solution of the primary container. It was a filamentous-like structured particulate indicative of mold.
An analysis of the primary container and overwrap revealed a puncture that had caused the container to leak.
Intravenous administration of a non-sterile product can result in infections that may be life-threatening and could result in prolonged hospitalization or organ failure.
However, Hospira has not received reports of any adverse events associated with this issue for this lot and has not identified any quality issues with retention samples for this lot.
Lactated Ringers and 5% Dextrose Injection is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container.
This lot (35-118-JT) was distributed nationwide—from December 2013 through February 2014—to hospitals, clinics, wholesalers, and distributors.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 (8am to 5pm EST, Monday through Friday) to arrange for the return of the product.
For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187 (available 24 hours a day, 7 days per week) or [email protected].
To report adverse events or product complaints, contact Hospira Global
Complaint Management at 1-800-441-4100 (8am to 5pm CT, Monday through Friday) or
Adverse events or quality problems can also be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program.
Image courtesy of Hospira
Hospira, Inc., has announced a US-wide, user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container (NDC 0409-7929-09, Lot 35-118-JT).
The company confirmed a report of particulate within the solution of the primary container. It was a filamentous-like structured particulate indicative of mold.
An analysis of the primary container and overwrap revealed a puncture that had caused the container to leak.
Intravenous administration of a non-sterile product can result in infections that may be life-threatening and could result in prolonged hospitalization or organ failure.
However, Hospira has not received reports of any adverse events associated with this issue for this lot and has not identified any quality issues with retention samples for this lot.
Lactated Ringers and 5% Dextrose Injection is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container.
This lot (35-118-JT) was distributed nationwide—from December 2013 through February 2014—to hospitals, clinics, wholesalers, and distributors.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 (8am to 5pm EST, Monday through Friday) to arrange for the return of the product.
For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187 (available 24 hours a day, 7 days per week) or [email protected].
To report adverse events or product complaints, contact Hospira Global
Complaint Management at 1-800-441-4100 (8am to 5pm CT, Monday through Friday) or
Adverse events or quality problems can also be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program.