Sodium chloride 9 mg/mL
SODIUM CHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Sodium chloride is a injection, solution containing sodium chloride at 9 mg/mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Sodium chloride
- Generic Name
- SODIUM CHLORIDE
- NDC Code (Product)
63323-623- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 9 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA207310
- Marketing Start
- 09/19/2017
Recall History
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
SCA Pharmaceuticals
Lack of Assurance of Sterility; product has the potential to leak.
SCA Pharmaceuticals
cGMP deviations: due to shipment of rejected units.
SterRx, LLC
Lack of Assurance of Sterility
SCA Pharmaceuticals, LLC
Lack of Assurance of Sterility
Cantrell Drug Company
Lack of Sterility Assurance.
Pharmedium Services, LLC
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
SCA Pharmaceuticals
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Teva North America
CGMP Deviations
SterRx, LLC
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 diluent or vehicle for other drugs, the manufacturer's recommendations should be followed. For use in cell washing, the manufacturer's recommendations for blood salvaging and red cell processing 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 .
Warnings
WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may cause hemolysis. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not heat over 66° C (150° F).
Contraindications
CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Adverse Reactions
ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, cells or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Frequently Asked Questions
What is Sodium chloride used for?
Sodium chloride contains SODIUM CHLORIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Sodium chloride a controlled substance?
Sodium chloride is not classified as a controlled substance by the DEA.
What is the generic name for Sodium chloride?
The generic name for Sodium chloride is SODIUM CHLORIDE. There are 12 other brand versions of SODIUM CHLORIDE.
What is the NDC code for Sodium chloride 9 mg/mL?
The NDC (National Drug Code) for Sodium chloride 9 mg/mL is 63323-623, listed by Fresenius Kabi USA, LLC.
Other Sodium Brands
See all →- Sodium Chloride9 mg/mL0487-4301
- Sterile Saline Mist Meijer.9 g/100g79481-0569
- Base Laboratories Saline30 mg/mL80327-013
- Sodium Chloride Normal Salt1 g/180513-608
- Sodium Chloride1000 mg/181033-028
- Hypertonic Saline70 mg/mL85202-000
- NATURAL LIQUIDMINERAL100 g/100mL87034-0003
- DIANEAL PD-2 with Dextrose25.7 mg/100mL0941-0415
- DIANEAL LOW CALCIUM WITH DEXTROSE18.3 mg/100mL0941-0694
- DIANEAL LOW CALCIUM WITH DEXTROSE18.3 mg/100mL0941-0696
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)