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FDA shortage status: Sterile Water Irrigant
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2023-04-28. Latest FDA row update: 2026-10-02.
FDA lists 9 package records, with companies: B. Braun Medical Inc., Baxter Healthcare, Baxter Healthcare Corporation, Otsuka ICU Medical LLC. Package NDCs: 0264-2101-00, 0264-2101-10, 0338-0004-02, 0338-0004-03, 0338-0004-04, 0990-6139-03, 0990-6139-22, 0990-7139-09, 0990-7139-36.
FDA shortage reason: Discontinuation of the manufacture of the drug; Other
This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.
FDA package and manufacturer records
| Company | Package NDC | Presentation | FDA availability field | FDA update |
|---|---|---|---|---|
| B. Braun Medical Inc. | 0264-2101-00 | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-00) | Available | 2026-09-22 |
| B. Braun Medical Inc. | 0264-2101-10 | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-10) | Available | 2026-09-22 |
| Baxter Healthcare | 0338-0004-02 | Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-02) | Available | 2026-10-02 |
| Baxter Healthcare | 0338-0004-03 | Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-03) | Limited Availability | 2026-10-02 |
| Baxter Healthcare | 0338-0004-04 | Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-04) | Available | 2026-10-02 |
| Otsuka ICU Medical LLC | 0990-6139-03 | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-6139-03) | Unavailable | 2026-10-01 |
| Otsuka ICU Medical LLC | 0990-6139-22 | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-6139-22) | Unavailable | 2026-10-01 |
| Otsuka ICU Medical LLC | 0990-7139-09 | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-7139-09) | Unavailable | 2026-10-01 |
| Otsuka ICU Medical LLC | 0990-7139-36 | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-7139-36) | Unavailable | 2026-10-01 |
Source facts
Grouped generic ingredient: Sterile Water Irrigant · 9 package records
Therapeutic categories: Gastroenterology, Other, Pediatric
Dosage forms: Irrigant
Routes: IRRIGATION
Open FDA source data · JSON · Markdown
FDA is authoritative. Source retrieved 2026-10-06T18:55:41+00:00. Derived grouping is documented in this record's derivations.