bacteriostatic water for injection in plastic container
Pharmaranks rates Bacteriostatic Water for Injection in Plastic Container 2.7/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Bacteriostatic Water for Injection in Plastic Container (Sterile Water for Injection) is a medication supplied as an injection, solution.
Sterile Water for Injection · by Hospira
Available as a generic: Sterile Water for Injection
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Sterile Water for Injection
- Form
- Injectable
- Strength
- Sterile Water FOR Injection 100%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Hospira
- FDA application
- NDA018802
What is Bacteriostatic Water for Injection in Plastic Container?
From the FDA label:The following preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. The pH is 5.7 (4.5 to 7.0). Water for Injection, USP is chemically designated H 2 O. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.
How to use
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 .
Side effects
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.
Warnings
Important safety information
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.
Who should not take Bacteriostatic Water for Injection in Plastic Container
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.
Overdose — what happens if you take too much
Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- How is Bacteriostatic Water for Injection in Plastic Container rated?
- pharmaranks gives Bacteriostatic Water for Injection in Plastic Container a composite score of 2.7 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Bacteriostatic Water for Injection in Plastic Container?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Bacteriostatic Water for Injection in Plastic Container. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Bacteriostatic Water for Injection in Plastic Container?
- Bacteriostatic Water for Injection in Plastic Container is marketed by Hospira. You can see Hospira's full profile, rating, and other products on pharmaranks.
- Is Bacteriostatic Water for Injection in Plastic Container a brand-name or generic drug?
- Bacteriostatic Water for Injection in Plastic Container is a brand-name product with the active ingredient Sterile Water for Injection. Lower-cost generic equivalents containing Sterile Water for Injection are available — ask your pharmacist.
- Is Bacteriostatic Water for Injection in Plastic Container available over the counter?
- No. Bacteriostatic Water for Injection in Plastic Container is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Bacteriostatic Water for Injection in Plastic Container come in?
- Bacteriostatic Water for Injection in Plastic Container is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Bacteriostatic Water for Injection in Plastic Container FDA-registered?
- Bacteriostatic Water for Injection in Plastic Container is on record with the U.S. FDA under application number NDA018802. You can verify this on its official FDA label.
- Has Bacteriostatic Water for Injection in Plastic Container been recalled by the FDA?
- Yes. Bacteriostatic Water for Injection in Plastic Container has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Bacteriostatic Water for Injection in Plastic Container safe?
- There's no single safe-or-not verdict. pharmaranks gives Bacteriostatic Water for Injection in Plastic Container a recall-safety score of 54/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Bacteriostatic Water for Injection in Plastic Container?
- Bacteriostatic Water for Injection in Plastic Container's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about STERILE WATER FOR INJECTION
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 952 reports naming STERILE WATER FOR INJECTION — the active ingredient in Bacteriostatic Water for Injection in Plastic Container, and the FDA flagged 53% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- myelosuppression90 reports
- nausea53 reports
- pyrexia51 reports
- product compounding quality issue49 reports
- fatigue40 reports
- vomiting36 reports
- white blood cell count decreased36 reports
- abdominal pain35 reports
Read these as a signal, not a rate. A report does not mean STERILE WATER FOR INJECTION caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
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bacteriostatic water for injection in plastic container
54/100