Shortage of Sterile Water Irrigant Affecting Availability
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Sterile Water Irrigant is currently in shortage due to discontinuation of manufacturing, with most supplies unavailable from Otsuka ICU Medical LLC as reported by the FDA.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on April 23, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Drug Shortages - determines the regulatory framework behind it, which shapes what mitigations (alternative therapies, allocation timelines, manufacturer guidance) are available and which agency holds oversight.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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Shortage of Sterile Water Irrigant
What's in Shortage
The generic drug Sterile Water Irrigant, with brand name STERILE WATER, is in irrigant dosage form and is currently in shortage. This shortage was first posted on April 28, 2023, and last updated on April 17, 2026. It falls under therapeutic categories including Gastroenterology, Other, and Pediatric.
Which Manufacturers Are Affected
The affected manufacturer is Otsuka ICU Medical LLC. Their availability statuses are as follows:
- For Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-6139-22): Unavailable. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions, contact 1-866-829-9025 or ProductAvailability@icumed.com.
- For Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-7139-36): Limited Availability, allocated to contracted customers only. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions, contact 1-866-829-9025 or ProductAvailability@icumed.com.
- For Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-7139-09): Unavailable. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions, contact 1-866-829-9025 or ProductAvailability@icumed.com.
- For Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-6139-03): Unavailable. Estimated recovery: TBD. This product is distributed by ICU Medical. For questions, contact 1-866-829-9025 or ProductAvailability@icumed.com.
Why There's a Shortage
The shortage is due to the discontinuation of the manufacture of the drug.
What Patients Should Do
Patients who depend on this medication should talk to their pharmacist or healthcare provider about the current status and possible options. They can also contact the manufacturer for more information. Please remember that patients should consult their healthcare provider for any medical advice and not make changes without professional guidance.
Source
This information is from the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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