section name header

Information

AHFS Class:

40:12 Replacement Preparations

Generic Name

Special Alerts:

Aughust 19, 2025

TOPIC: B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter

ISSUE: B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container.

For more information about this recall, see the full announcement on the FDA website: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-1000-ml-and-09.

Products

Sodium chloride additive solution is available as a preservative-free concentrate for injection in concentrations of 14.6 and 23.4% in various size containers.3860; 3861 A pharmacy bulk package may be available.3861 The 14.6% concentration contains sodium chloride 146 mg/mL and provides 2.5 mEq/mL of sodium and chloride ions.3860 The 23.4% concentration contains sodium chloride 234 mg/mL and provides 4 mEq/mL of sodium and chloride ions.3861

NOTE: Do not confuse these high concentration additive solutions with other sodium chloride products with lower concentrations.

Sodium chloride 0.45 and 0.9% infusion solutions are available in a variety of sizes from 25 to 1000 mL.3862 The 0.45 and 0.9% concentrations provide 77 and 154 mEq, respectively, of sodium and chloride per liter.3862

Sodium chloride 3 and 5% hypertonic infusion solutions are available in 500 mL flexible plastic containers.3863 The 3% concentration contains sodium chloride 30 g/L and provides 513 mEq/L of sodium and chloride ions.3863 The 5% concentration contains sodium chloride 50 g/L and provides 856 mEq/L of sodium and chloride ions.3863

pH

From 4.5 to 7.3860; 3861; 3862; 3863

Osmolarity

Sodium chloride additive solutions are very hypertonic and must be diluted for use. The osmolarities of the 14.6 and 23.4% concentrations have been calculated to be about 5000 and 8000 mOsm/L, respectively.3860; 3861 The osmolality of the 14.6% concentration was determined to be 5370 mOsm/kg by freezing-point depression and 4783 mOsm/kg by vapor pressure.1071

A 0.9% sodium chloride solution is isotonic, having a calculated osmolarity of 308 mOsm/L.3862 A 0.45% sodium chloride solution is hypotonic, having a calculated osmolarity of 154 mOsm/L.3862

Sodium chloride 3 and 5% solutions are hypertonic, having a calculated osmolarity of 1027 and 1711 mOsm/L, respectively.3863

Administration

Sodium chloride additive solutions of 14.6 and 23.4% are administered by intravenous infusion only after dilution in a larger volume of fluid.3860; 3861 Infusion solutions that are hypertonic (e.g., sodium chloride 3 or 5%) should be administered into a large vein.3863

Stability

Intact containers of sodium chloride additive solution should be stored at controlled room temperature.3860 Unused portions of single-dose vials should be discarded.3860

The closure of pharmacy bulk packages may be penetrated one time with a suitable sterile dispensing set or transfer device.3861 Pharmacy bulk packages should be discarded within 4 hours of initial entry.3861

Commercially-available sodium chloride infusion solutions (e.g., 0.45, 0.9, 3, 5%) should be stored at room temperature and protected from excessive heat.3862; 3863

Elastomeric Reservoir Pumps

Sodium chloride 0.9% (Baxter) 250 mL was filled into Intermate LV 250 (Baxter) elastomeric infusion devices and stored at 5 and 23°C for 90 days. The solution remained visually compatible with no change in pH and sodium or chloride concentration and less than 0.1% water loss.1993

Standardize 4 Safety

One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.

Table 1. Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Sodium Chloride3635

Patient PopulationConcentration StandardsDosing Units
Pediatric patients (50 kg)0.5 mEq/mL (3%)mL/kg/hour or mEq/kg/hour, depending on institution protocols

Compatibility

Solution Compatibility

Additive Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

Other Info

References

For a list of references cited in the text of this monograph, search the monograph titled References.

Copyrights

ASHP® Injectable Drug InformationTM. Selected Revisions September 12, 2025. © Copyright, 2025. American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.