ICU Medical 0.9% Sodium Chloride Injection recalled due to potassium chloride product mix-up
What this means
One lot of ICU Medical 0.9% Sodium Chloride Injection (a salt solution) was found to contain 10 mEq Potassium Chloride Injection instead. The vial had the correct outer label but the wrong product inside. This was discovered through a customer complaint.
- If you work in a hospital, pharmacy, or medical facility, check your inventory for lot 1042188 (NDC 0990-7984-23, expiration 31 October 2027).
- Do not use any units from this lot. Quarantine and set them aside immediately.
- Contact ICU Medical Customer Service at 1-800-258-5361 or customerservice@icumed.com for return instructions.
- Report any adverse events to FDA MedWatch at 1-800-332-1088 or www.fda.gov/medwatch/report.htm.
Product photos
The agency's original wording
Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with la
Official notice
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-dueWant us to check the next one for you?
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