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Otsuka Icu Medical LLC

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Class I

  • The FDA’s most serious category — a reasonable probability of serious harm or death.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check with your pharmacist Filed 2025-11-26

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

Check these codes: Lot # 1030613, Exp Date: 09/30/2026

21,696 50mL flexible containers · distributed us nationwide. Recall D-0180-2026 on FDA.gov ↗
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