Hospira Bacteriostatic Water: Vial Sizes, 0.9% vs 1.1%, and What the Label Says

1. Hospira and Pfizer Bacteriostatic Water: Why This Page Reads the Label

Hospira, part of Pfizer, is the name most people picture when they think of bacteriostatic water, so Pfizer bacteriostatic water and Hospira bacteriostatic water are the same product: Hospira Bacteriostatic Water for Injection, USP, sold under Hospira’s own NDCs. Most comparisons written about it are assembled from forum memory. Almost everything worth knowing is stated plainly on the FDA-approved label, so that is the source used throughout this page.¹

One correction up front, because it is the most repeated error in this category: there is no single “Hospira bac water.” There are two presentations, and they differ in size, container material and preservative strength.

2. The Two Presentations, Side by Side

All values above are taken from the FDA-approved label and its DailyMed product listing.¹

The vial and the tray carry different NDCs. The last segment changes: -01 is a single 30 mL plastic vial and -03 is the tray of 25 it ships in.¹ A loose vial from a split tray should therefore show 0409-3977-01, not the tray code. FDA’s 2019 recall notice for this product lists both numbers the same way, vial and carton.²

Both presentations use a 30 mL container, and that is not a coincidence of packaging. The USP monograph for Bacteriostatic Water for Injection limits it to containers not larger than 30 mL.³ The glass presentation simply puts 20 mL of the stronger 1.1% solution into a vial at that ceiling.

A listing detail to check before you order the glass vial

The label text still describes both presentations, and Pfizer’s medical information site still lists both NDCs.⁵ The structured product data behind the label is less even. In Hospira’s current DailyMed listing, the 30 mL plastic product (0409-3977) has a marketing start date and no end date. The 20 mL glass product (0409-1093) has a marketing end date entered, the same day as its start date, April 30, 2005.¹

That field matters because FDA’s NDC Directory only carries listings that have reached their marketing start date and have not reached their end date.⁶ When we checked FDA’s NDC data in September 2026, 0409-3977 was listed and 0409-1093 was not. We cannot tell from the public record whether that reflects a discontinuation or a data entry, so we are not calling it one. The practical point is narrower: the 30 mL plastic 0.9% vial is the Hospira product that every other listing and shortage record points to, and if a drug’s instructions call for the 1.1% glass presentation, confirm it is available before you plan around it.

3. What Both Presentations Commit To

Beyond the packaging differences, both share the label’s substantive terms, and these are the ones that matter clinically:

• Composition: “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.”¹
• Indication: “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.”¹
• Neonates: NOT FOR USE IN NEONATES. The label states that “due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population.”¹
• Fluid replacement: “Parenteral preparations with benzyl alcohol should not be used for fluid replacement.”¹

The 28-day re-entry limit is not on the drug label. It comes from USP <797> and CDC injection safety guidance, which apply to opened multiple-dose vials generally.⁷ See the 28-day puncture rule.

4. Relabeling: Why an Unfamiliar Name Isn’t Automatically a Red Flag

The same FDA-approved product reaches buyers under more than one labeler. A 30 mL multiple-dose bacteriostatic water listing appears on DailyMed under Henry Schein, Inc. as labeler, with its own NDC (0404-9970-30), carrying the identical description language: the same polyolefin copolymer container, the same 0.9%/1.1% composition statement, the same pH 5.7 (4.5 to 7.0), the same 20 to 25°C storage direction.⁸

Henry Schein is not alone. When we searched DailyMed for bacteriostatic water in September 2026, the results included five relabeler or repackager listings: Henry Schein, HealthFirst, US MedSource, Medical Purchasing Solutions and ProPharma Distribution. Each one names Hospira’s 0409-3977 as the source NDC and cites Hospira’s application, NDA 018802. None of them lists the glass 0409-1093 presentation as its source.^89101112

This matters for verification. Seeing a distributor’s name rather than Hospira’s on a carton is normal and does not by itself indicate a counterfeit. The thing to check is the NDC and whether the labeling matches an approved product, both of which you can look up on DailyMed yourself. Conversely, a product that carries Hospira’s trade dress but no traceable NDC is the actual warning sign. Our guide to reading a COA covers the rest of that check.

5. Supply Status: What We Found When We Lined Up the FDA and ASHP Records

Scarcity is a common selling argument in this category, and it can be checked. There are two national shortage lists in the United States, and in September 2026 they gave different answers for this product. Both were accurate on their own terms, which is why the rest of this section is worth reading before you believe any seller, including us.

FDA: no entry

FDA’s Drug Shortages database covers current and resolved shortages reported to the agency. When we searched it on September 27, 2026, it had no bacteriostatic water entry, current or resolved. Sterile Water Injection and Sterile Water Irrigant, which are different products, were listed as currently in shortage. FDA marks a shortage resolved when supply from at least one manufacturer covers total market demand, and notes that some manufacturers may still not have every presentation available.¹³

ASHP: a current shortage bulletin

The American Society of Health-System Pharmacists (ASHP) publishes shortage bulletins written by the University of Utah Drug Information Service. Its bulletin for Bacteriostatic Water for Injection, created July 15, 2025 and still posted in September 2026, lists one affected product: Pfizer’s 30 mL vial, tray of 25, NDC 0409-3977-03. Under available products it says there is insufficient supply for usual ordering, and under resupply that Pfizer has the 30 mL vials in limited supply.¹⁴ The bulletin’s reason for the shortage is two sentences long:

“Sole suppliers” is the phrase to hold on to. Drugs@FDA lists one bacteriostatic water application with a prescription marketing status, Hospira’s NDA 018802, first approved on October 27, 1982.¹⁵ Two other applications, both held by Abraxis Pharm, are marked discontinued.¹⁶¹⁷ Every relabeled vial described in section 4 traces back to that one application, so when Hospira’s production slips there is no second approved source to fill the gap.

Why the two lists disagree

The lists measure different things. FDA lists a drug when manufacturers cannot meet national demand. ASHP lists a shortage when it is confirmed with the manufacturer and it changes how a pharmacy prepares or dispenses a product, or forces the use of an alternative. ASHP resolves a shortage only when every manufacturer has restored every formulation and size to full availability, and its own comparison page notes that ASHP frequently lists more shortages than FDA.¹⁸ A one-manufacturer product on allocation can sit on the ASHP list while never meeting FDA’s bar.

That pattern is common for older injectables. The pharmacist whose team supplies ASHP’s shortage data put it this way in 2024:

The record so far

This is not the first supply entry for the product. ASHP opened an earlier bulletin on November 16, 2021, giving increased demand as the reason, and updated it on March 6, 2023 to say Pfizer had 30 mL vials available.¹⁹ Separately, on September 6, 2019, Hospira recalled one lot of the 30 mL vial (lot W20308, distributed March to April 2018) because sterilization could not be confirmed for some vials.²

6. Comparing Any Supplier Against the Hospira Label

The useful way to use this page is as a baseline. When you evaluate any bacteriostatic water, the Hospira label gives you the reference points that a competing product should be able to match or explain:

1. Preservative strength stated as a number. 9 mg/mL or 11 mg/mL, not “contains benzyl alcohol.”
2. A pH specification. 4.5 to 7.0 is the published range.¹
3. An endotoxin limit, and the right one. FDA’s inspection guide records 0.5 EU/mL for Bacteriostatic Water for Injection, against 0.25 EU/mL for plain Water for Injection; a supplier quoting a limit should be quoting the former.²⁰
4. A named container material. Polyolefin and Type I glass are both legitimate; vagueness is not.⁴
5. A storage direction. 20 to 25°C, and a fulfilment process that respects it.

A supplier who differs from Hospira on any of these is not automatically worse. Different vial sizes and container choices serve different protocols, which is the subject of 10 mL vs 3 mL sizing. What matters is that the difference is stated in numbers you can check, rather than asserted in adjectives.