Otsuka Icu Medical LLC: FDA regulatory profile
Otsuka Icu Medical LLC appears in 5 indexed U.S. FDA records: 5 drug-shortage entries (from 9 openFDA source rows), naming 5 distinct products. Latest dated event: a shortage record dated 2026-08-17. Observations run 2020-12-08 to 2026-08-17 — 2078 days, 10 dated records across 5 calendar years, busiest 2026 with 5. Shortages: 5 current, averaging 1.8 package lines each across 4 FDA therapeutic categories, 6 strengths, 67 package NDCs and 10 brand names. 3 related firms and 8 adjacent shortage entries are linked below, each by a shared shortage entry, substance or therapeutic category. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. By year: 2026 (5), 2024 (1), 2023 (1), 2022 (2), 2020 (1). Shortage entries include Amino Acid Injection (Current, since 2020-12-08, 2 lines), Dextrose Monohydrate 10% Injection (Current, since 2022-03-01, 1 lines), Dextrose Monohydrate 5% Injection (Current, since 2022-02-14, 4 lines) and Dextrose Monohydrate 70% Injection (Current, since 2024-10-11, 1 lines).
Regulatory snapshot
| Indexed records | 5 |
|---|---|
| Recall records | 0 |
| Shortage entries | 5 |
| Source rows filed | 9 |
| Approval records | 0 |
| Current shortages | 5 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 5 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| First observed | 2020-12-08 |
| Latest observed | 2026-08-17 |
| Latest event type | shortage |
| Dated observations | 10 |
| Years covered | 5 |
| Span (days) | 2078 |
| Busiest year | 2026 (5 records) |
| Lines per entry (mean) | 1.8 |
| Therapeutic categories | 4 |
| Distinct strengths | 6 |
| Package NDCs | 67 |
| Brand names | 10 |
| Related firms / shortages | 3 / 8 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Shortage status | Current | 5 | 100% |
| Therapeutic category | Gastroenterology | 5 | 100% |
| Therapeutic category | Other | 4 | 80% |
| Therapeutic category | Pediatric | 4 | 80% |
| Therapeutic category | Endocrinology/Metabolism | 3 | 60% |
Current shortages (5)
Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.
| Shortage | Status | Since | Updated | Lines filed | Presentations | Strengths |
|---|---|---|---|---|---|---|
| Amino Acid Injection (Aminosyn II, Aminosyn II 10 %, Aminosyn II 15%, Clinisol, Clinisol 15, Plenamine, Premasol, Premasol - Sulfite-free (amino Acid), Travasol, Travasol 10) | Current | 2020-12-08 | 2026-08-17 | 2 | 2 | 0.1, 0.15 |
| Dextrose Monohydrate 10% Injection | Current | 2022-03-01 | 2026-08-17 | 1 | 1 | 10 g/100 mL |
| Dextrose Monohydrate 5% Injection | Current | 2022-02-14 | 2026-08-17 | 4 | 4 | 5 g/100 mL |
| Dextrose Monohydrate 70% Injection | Current | 2024-10-11 | 2026-08-17 | 1 | 1 | 70 g/100 mL |
| Sterile Water Irrigant | Current | 2023-04-28 | 2026-08-17 | 1 | 1 | 1 mL/1 mL |
Package lines filed (9)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Amino Acid Injection | Aminosyn II 15% In Plastic Container, Injection, 0.15 (NDC 0990-7171-17) | 0.15 | 0990-7171-17 | Current | Available | 2026-08-17 |
| Amino Acid Injection | Aminosyn II 10% In Plastic Container, Injection, 0.1 (NDC 0990-7172-17) | 0.1 | 0990-7172-17 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 10% Injection | Dextrose 10% In Plastic Container, Injection, 10 g/100 mL (NDC 0990-7930-09) | 10 g/100 mL | 0990-7930-09 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0990-7922-03) | 5 g/100 mL | 0990-7922-03 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0990-7923-20) | 5 g/100 mL | 0990-7923-20 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0990-7923-37) | 5 g/100 mL | 0990-7923-37 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0990-7922-55) | 5 g/100 mL | 0990-7922-55 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 70% Injection | DEXTROSE 70% IN PLASTIC CONTAINER, Injection, 70 g/100 mL (NDC 0990-7918-19) | 70 g/100 mL | 0990-7918-19 | Current | Available | 2026-08-17 |
| Sterile Water Irrigant | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0990-6139-22) | 1 mL/1 mL | 0990-6139-22 | Current | Unavailable | 2026-08-17 |
Products and drugs named (5)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amino Acid Injection | shortage | 2 | 2026-08-17 |
| Dextrose Monohydrate 10% Injection | shortage | 1 | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | shortage | 4 | 2026-08-17 |
| Dextrose Monohydrate 70% Injection | shortage | 1 | 2026-08-17 |
| Sterile Water Irrigant | shortage | 1 | 2026-08-17 |
Indexed activity by year
Counts within the ingested window across 10 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 0 | 5 | 0 | 5 |
| 2024 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 1 | 0 | 1 |
Related manufacturers
Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.
| Firm | Relation | Records | Recalls | Shortages | Latest |
|---|---|---|---|---|---|
| Baxter Healthcare | co-reports the same shortage; reports a shortage of the same substance | 14 | 0 | 14 | 2026-08-20 |
| Amphastar Pharmaceuticals, Inc. | reports a shortage of the same substance | 6 | 0 | 6 | 2026-08-18 |
| Medefil, Inc. | reports a shortage of the same substance | 1 | 0 | 1 | 2026-08-17 |
Related shortages in this firm's areas
Not reported by this firm, but sharing a substance identifier or therapeutic category with one that is.
| Shortage | Status | Relation | Since | Updated | Presentations | Firms |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Current | same therapeutic category | 2019-02-08 | 2026-08-20 | 4 | 1 |
| Sodium Bicarbonate Injection | Current | same therapeutic category | 2017-03-01 | 2026-08-18 | 2 | 2 |
| Dextrose Monohydrate 50% Injection | Current | same therapeutic category | 2022-01-13 | 2026-08-18 | 1 | 1 |
| Atropine Sulfate Injection | Current | same therapeutic category | 2012-01-01 | 2026-08-18 | 6 | 3 |
| Lidocaine Hydrochloride Injection | Current | same therapeutic category | 2012-02-22 | 2026-08-18 | 2 | 2 |
| Clonazepam Tablet | Current | same therapeutic category | 2023-03-10 | 2026-08-17 | 6 | 3 |
| Dobutamine Hydrochloride Injection | Current | same therapeutic category | 2017-11-06 | 2026-08-17 | 1 | 1 |
| Ifosfamide Injection | Current | same therapeutic category | 2026-06-12 | 2026-08-17 | 1 | 1 |
Source limitations
Built from the 5 ingested FDA records for this firm (0 recall, 5 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.