WARNING - FDA records indicate that this drug has been recalled.

Baxter Healthcare Corp.

Product Description:	Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Status:	Ongoing
City:	Deerfield
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Letter
Distribution Pattern:	US, Puerto Rico, and Bermuda
Classification:	Class I
Product Quantity:	58,932 bags
Reason For Recall:	Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall Initiation Date:	20150324
Report Date:	20150715

Hospira Inc.

Product Description:	LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
Status:	Ongoing
City:	Lake Forest
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Letter
Distribution Pattern:	Nationwide
Classification:	Class I
Product Quantity:	24,744 flexible container bags
Reason For Recall:	Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Recall Initiation Date:	20150311
Report Date:	20150603

Baxter Healthcare Corp.

Product Description:	Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Status:	Ongoing
City:	Deerfield
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Letter
Distribution Pattern:	US, Puerto Rico, and Bermuda
Classification:	Class I
Product Quantity:	58,932 bags
Reason For Recall:	Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall Initiation Date:	20150324
Report Date:	20150715

Lactated Ringers

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Lactated Ringers Recall

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Side Effects & Adverse Reactions

WARNING: Do not administer to horses by intraperitoneal injection. Do not administer to animals with inadequate renal function. Not for use in lactic acidosis.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

INDICATIONS: For the correction of electrolyte depletion, metabolic acidosis and dehydration of cattle, calves, horses, sheep and swine.

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History

There is currently no drug history available for this drug.

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Other Information

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Lactated Ringers Manufacturers

Rxv

Lactated Ringers | Rxv

DOSAGE AND ADMINISTRATION:

May be injected intravenously, subcutaneously or intraperitoneally (except in horses) using strict aseptic technique.

Cattle and Horses: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

Swine and Sheep: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed. If administered subcutaneously divide the dosage into several sites of injection and massage points of injection to aid in absorption and help prevent inflammation and / or sloughing.

No Recall
Rxv Products

Lactated Ringers | Rxv Products

May be injected intravenously, subcutaneously or intraperitoneally (except in horses) using strict aseptic technique.
Cattle and Horses: 2 - 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.
Swine and Sheep: 2 - 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.
If administered subcutaneously divide the dosage into several sites of injection and massage points of injection to aid in absorption and help prevent inflammation and/or sloughing.

No Recall
Baxter Healthcare Corporation

Lactated Ringers | Baxter Healthcare Corporation

As directed by a physician.

Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

No Recall
B. Braun Medical Inc.

Lactated Ringers | B. Braun Medical Inc.

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

The presence of calcium ions in this solution should be considered when phosphate is present in additive solutions, in order to avoid precipitation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Baxter Healthcare Corporation

Lactated Ringers | Baxter Healthcare Corporation

The volume of slushed solution required will vary with patient’s age, clinical condition, cooling effect desired and duration of cooling effect desired, according to physician’s instructions.

No Recall
Remedyrepack Inc.

Lactated Ringers | Remedyrepack Inc.

As directed by a physician. Dosage, rate and duration of administration are to be individualized and dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and seal is intact.

When making additions to Lactated Ringer’s Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

Additives may be incompatible with Lactated Ringer’s Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Lactated Ringer’s Injection, USP is appropriate.

The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.

Recall
A & G Pharmaceuticals, Inc.

Lactated Ringers | A & G Pharmaceuticals, Inc.

DOSAGE AND ADMINISTRATION: May be injected intravenously, subcutaneously or intraperitoneally (except in horses) using strict aseptic technique.

Cattle and Horses: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

Swine and Sheep: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

If administered subcutaneously divide the dosage into several sites of injection and massage points of injection to aid in absorption and help prevent inflammation and/or sloughing.

No Recall
Hospira, Inc.

Lactated Ringers | Hospira, Inc.

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed.

Tear at notch and along dotted line and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS.)

No Recall
B. Braun Medical Inc.

Lactated Ringers | B. Braun Medical Inc.

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer's recommendations should be followed.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

No Recall
Baxter Healthcare Corporation

Lactated Ringers | Baxter Healthcare Corporation

As directed by a physician. Dosage, rate and duration of administration are to be individualized and dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and seal is intact.

When making additions to Lactated Ringer’s Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

Additives may be incompatible with Lactated Ringer’s Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Lactated Ringer’s Injection, USP is appropriate.

The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.

No Recall
Baxter Healthcare Corporation

Lactated Ringers | Baxter Healthcare Corporation

As directed by a physician. Dosage, rate, and duration of administration are to be individualized and dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.

All injections in AVIVA plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and seal is intact.

When making additions to Lactated Ringer’s Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

Additives may be incompatible with Lactated Ringer’s Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Lactated Ringer’s Injection, USP is appropriate.

The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.

No Recall
Vettek

Lactated Ringers | Vettek

May be injected intravenously, subcutaneously or intraperitoneally (except in horses) using strict aseptic technique.

Cattle and Horses: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

Swine and Sheep: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

If administered subcutaneously divide the dosage into several sites of injection and massage points of injection to aid in absorption and help prevent inflammation and/or sloughing.

No Recall
Mwi (Vetone)

Lactated Ringers | Mwi (vetone)

May be injected intravenously, subcutaneously or intraperitoneally (except in horses) using strict aseptic technique.

Cattle and Horses: 2 to 5 mL per pound of body weight, depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

Swine and Sheep: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

If administered subcutaneously divide dosage into several sites of injection and massage points of injection to aid in absorption and help prevent inflammation and/or sloughing.

No Recall
Animart

Lactated Ringers | Animart

May be injected intravenously, subcutaneously or intraperitoneally (except in horses) using strict aseptic technique.

Cattle and Horses: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

Swine and Sheep: 2 to 5 mL per pound of body weight depending on size and condition of animal, repeated 1 to 3 times daily or as needed.

If administered subcutaneously divide the dosage into several sites of injection and massage points of injection to aid in absorption and help prevent inflammation and/or sloughing.

No Recall
Baxter Healthcare Corporation

Lactated Ringers | Baxter Healthcare Corporation

The volume and/or rate of solution needed will vary with the nature and duration of the arthroscopic procedure.

This solution, as it is packaged, is not intended for IV administration or injection.

The container must not be vented (See Precautions).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact. If particulate matter or discoloration is found, contact Baxter Customer Service

Aseptic technique should be used when applying this product.

The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

When using Lactated Ringer’s Irrigation for pour irrigation, prevent contact of the fluid with the external surface of the container.

Lactated Ringer’s Irrigation is for single-patient use only.

Microwave heating of irrigation fluids is not recommended. If desired, Lactated Ringer’s Irrigation may be warmed in a water bath or oven to not more than 45° C while maintaining sterility. Lactated Ringer’s Irrigation that has been warmed must not be returned to storage.

Cetriaxone must not be mixed with calcium-containing solutions, including Lactated Ringer’s Irrigation.

Additives may be incompatible with Lactated Ringer’s Irrigation. Additives known or determined to be incompatible should not be used.

As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for, for example, a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Lactated Ringer’s Irrigation is appropriate.

The instructions for use of the medication to be added and other relevant literature must be consulted.

When making additions to Lactated Ringer’s Irrigation, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

No Recall