Recall of lot P262766 of Baxter's Potassium Chloride (KCl) Injection Highly Concentrated (200 mEq/L) due to failure to meet endotoxin specifications

Baxter Healthcare (Asia) Pte. Ltd, in consultation with the Health Sciences Authority (HSA), is voluntarily recalling one lot of Highly Concentrated Potassium Chloride Injection (Lot No: P262766) on the June 6, 2011 due to an error in programming of the Bacterial Endotoxin Test (BET) analytical instrument. An investigation uncovered that a programming error in the BET analytical instrument and subsequent misinterpretation of the test data could have resulted in a specific batch of the Highly Concentrated Potassium Chloride Injection not meeting endotoxin specifications. Although the test results of the reserved batch samples have met specifications requirements, as a precautionary measure, Baxter is voluntarily recalling the affected batch due to the possible test errors described above. Baxter has reviewed their records of adverse events received and have found no adverse events being reported for the above mentioned batch. Nevertheless, if Highly Concentrated Potassium Chloride Injection (Lot No: P262766) was administered to your patient shortly before this recall notice, healthcare professionals are advised to monitor them closely for the effects of endotoxin exposure. Published: 8 Jun 2011

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