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OFFICIAL-SOURCE RECALL · UNITED STATES

ICU Medical LLC 0.9% Sodium Chloride Injection, USP, 100 mL Recall: Product mix-up where 0

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CountryUnited StatesPublishedSeptember 21, 2026Last updatedSeptember 21, 2026Official source last checkedOctober 2, 2026 at 8:33 PM UTC

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Is your product affected?

Brand
ICU Medical LLC
Product
0.9% Sodium Chloride Injection, USP, 100 mL
Manufacturer
Otsuka ICU Medical LLC
GTIN
30309907984231
NDC
0990-7984-23, NDCNumber
Lot number
1042188, 1035181
Expiration date
31 October 2027, Configuration
Package size
100mL, 100 mL

The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection

Hazard

Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection

Official recall notice

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection

Agency: U.S. Food & Drug Administration

Official publication date: September 21, 2026

Read the official FDA recall notice →

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