Bacteriostatic Water 1 mL/mL
Bacteriostatic Water · INJECTION, SOLUTION · Hospira, Inc.
Bacteriostatic Water is a injection, solution containing bacteriostatic water at 1 mL/mL, taken intramuscular. Manufactured by Hospira, Inc..
Key Facts
- Brand Name
- Bacteriostatic Water
- Generic Name
- Bacteriostatic Water
- NDC Code (Product)
0409-3977- Manufacturer
- Hospira, Inc.
- Strength
- 1 mL/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- NDA018802
- Marketing Start
- 04/30/2005
Recall History
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Pallimed Solutions
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Pfizer Inc.
Lack of Assurance of Sterility
GenoGenix LLC
Lack of Assurance of Sterility
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Pharm D Solutions, LLC
Lack of Sterility Assurance.
Genentech Inc
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Pharm D Solutions, 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 parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Dosage & Administration
DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Warnings
WARNINGS Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used. Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.
Contraindications
CONTRAINDICATIONS Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for fluid replacement. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use.
Adverse Reactions
ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes.
Frequently Asked Questions
What is Bacteriostatic Water used for?
Bacteriostatic Water contains Bacteriostatic Water. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Bacteriostatic Water a controlled substance?
Bacteriostatic Water is not classified as a controlled substance by the DEA.
What is the generic name for Bacteriostatic Water?
The generic name for Bacteriostatic Water is Bacteriostatic Water. There are 3 other brand versions of Bacteriostatic Water.
What is the NDC code for Bacteriostatic Water 1 mL/mL?
The NDC (National Drug Code) for Bacteriostatic Water 1 mL/mL is 0409-3977, listed by Hospira, Inc..