ICU Medical Inc.
NDC labeler code: 0990
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Dextrose monohydrateInfant Dextrose · 10 products
- Dextrose monohydrate, sodium chloride, and potassium chloride7 products
- Sodium chlorideBacteriostatic Sodium Chloride · 6 products
- Dextrose monohydrate and sodium chloride4 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 3 products
- WaterSterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys · 3 products
- Sodium chloride and potassium chloride3 products
- Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chlorideNormosol-R, Multiple Electrolytes Ph 7.4, Plasma-Lyte a · 2 products
- Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrateLactated Ringers and Dextrose, Potassium Chloride in Lactated Ringers and Dextrose, Dextrose in Lactated Ringers · 2 products
- Sodium chloride, sodium lactate, potassium chloride, and calcium chlorideLactated Ringers, Lactated Ringers Irrigation · 2 products
- Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosineAminosyn-Pf · 2 products
- Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycineAminosyn II · 2 products
- Dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetateNormosol-M and Dextrose · 1 product
- MannitolOsmitrol · 1 product
- Potassium chloride, dextrose monohydrate1 product
- Dextrose monohydrate, sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, monobasic, and sodium phosphate, monobasic, monohydrateIonosol Mb and Dextrose · 1 product
- Sorbitol and mannitol1 product
- Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chlorideNormosol-R and Dextrose · 1 product
- Glycine1 product
- Sodium chloride, potassium chloride, and calcium chlorideRingers · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 10, 2008 | ANDA078446 | Sodium chloride and potassium chloride POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| November 30, 1992 | NDA020161 | Potassium chloride POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| December 19, 1991 | NDA020015 | Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine AMINOSYN II 10% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| December 19, 1991 | NDA020041 | Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine AMINOSYN II 15% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| December 26, 1989 | NDA019869 | Water STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| December 26, 1989 | NDA019893 | Dextrose monohydrate DEXTROSE 70% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| October 17, 1988 | NDA019685 | Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| October 17, 1988 | NDA019686 | Sodium chloride and potassium chloride POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| March 24, 1988 | NDA019691 | Dextrose monohydrate, sodium chloride, and potassium chloride POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| January 8, 1987 | NDA019603 | Mannitol MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL 20% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| October 17, 1986 | NDA019492 | Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine AMINOSYN-PF 10% | Otsuka Icu Medcl |
| May 8, 1986 | NDA019513 | Dextrose monohydrate, sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, monobasic, and sodium phosphate, monobasic, monohydrate IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| January 17, 1986 | NDA019416 | Sodium chloride, sodium lactate, potassium chloride, and calcium chloride LACTATED RINGER'S IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| September 6, 1985 | NDA019398 | Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine AMINOSYN-PF 7% | Otsuka Icu Medcl |
| January 26, 1985 | NDA019345 | Dextrose monohydrate DEXTROSE 30% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| March 23, 1982 | NDA018561 | Dextrose monohydrate DEXTROSE 70% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| March 23, 1982 | NDA018562 | Dextrose monohydrate DEXTROSE 40% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| March 23, 1982 | NDA018563 | Dextrose monohydrate DEXTROSE 50% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| March 23, 1982 | NDA018564 | Dextrose monohydrate DEXTROSE 20% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| May 29, 1980 | NDA018362 | Dextrose monohydrate, sodium chloride, and potassium chloride POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| May 29, 1980 | NDA018365 | Dextrose monohydrate, sodium chloride, and potassium chloride POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| May 29, 1980 | NDA018371 | Potassium chloride, dextrose monohydrate POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| May 16, 1980 | NDA018251 | Sodium chloride, potassium chloride, and calcium chloride RINGER'S IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| February 22, 1980 | NDA018313 | Water STERILE WATER IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| February 22, 1980 | NDA018314 | Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| February 22, 1980 | NDA018315 | Glycine GLYCINE 1.5% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| February 22, 1980 | NDA018316 | Sorbitol and mannitol SORBITOL-MANNITOL IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| February 18, 1980 | NDA018233 | Water STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| August 28, 1979 | NDA018080 | Dextrose monohydrate DEXTROSE 10% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| April 4, 1979 | NDA018090 | Sodium chloride SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| April 12, 1977 | NDA017799 | Dextrose monohydrate and sodium chloride DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| January 26, 1976 | NDA017641 | Sodium chloride, sodium lactate, potassium chloride, and calcium chloride LACTATED RINGER'S IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| January 7, 1976 | NDA017585 | Dextrose monohydrate and sodium chloride DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| August 13, 1975 | NDA017586 | Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride NORMOSOL-R IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| August 13, 1975 | NDA017606 | Dextrose monohydrate and sodium chloride DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| August 13, 1975 | NDA017607 | Dextrose monohydrate and sodium chloride DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| August 13, 1975 | NDA017608 | Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| August 13, 1975 | NDA017609 | Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| August 13, 1975 | NDA017610 | Dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| February 24, 1972 | NDA016366 | Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
| February 12, 1971 | NDA016367 | Dextrose monohydrate DEXTROSE 5% IN PLASTIC CONTAINER | Otsuka Icu Medcl |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
October 29, 2025 · Class I · Ongoing · D-0180-2026 · Potassium chloride
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
-
October 29, 2025 · Class I · Ongoing · D-0181-2026 · Potassium chloride
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
-
October 27, 2025 · Class II · Ongoing · D-0143-2026 · Sodium chloride
Lack of Assurance of Sterility: Potential for flexible container leaks.
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
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February 13, 2025 · Class I · Ongoing · D-0268-2025 · Potassium chloride
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
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February 13, 2025 · Class I · Ongoing · D-0267-2025 · Potassium chloride
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266;
2022
-
November 9, 2022 · Class II · Ongoing · D-0062-2023 · Sodium chloride
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
2021
-
March 9, 2021 · Class II · Terminated · D-0313-2021 · Sodium chloride
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026