FDA (Drugs) recall action 97888
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
Otsuka ICU Medical is recalling one lot of Potassium Chloride Injection because the overwrap label may state 10 mEq when the product is 20 mEq. The FDA classified it Class I.
Otsuka ICU Medical is recalling 21,696 containers of Potassium Chloride Injection 20 mEq in 50 mL because the overwrap may state 10 mEq. The FDA classified it Class I.