Baxter Voluntarily Recalls One Lot of Potassium Chloride Due to Labeling Error

Baxter International Inc. is voluntarily recalling one lot of potassium chloride injection 10 m Eq per 100 mL, product code 2B0826, to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot, which was identified by three customers. Shipping cartons labeled for this specific lot number of potassium chloride injection may contain units of gentamicin sulfate Injection, 80 mg in 100 mL, product code 2B0862.

Potassium chloride is indicated for treatment of potassium deficiency and administered intravenously. Gentamicin sulfate is an antibacterial drug for intravenous administration.

As both products are packaged in 100-mL containers, have similar code numbers and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.

The affected lot of potassium chloride injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014.

Baxter also is voluntarily recalling 157,080 containers of 9% sodium chloride Injection, USP, 500 mL, Viaflex Plastic Container, due to a lack of assurance of sterility based on complaints of mold in the overpouch. The Class II recall was initiated nationwide by the company on July 30, 2014, and reported in the US Food and Drug Administration’s Weekly Enforcement Report of September 17, 2014. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Source: FDA (potassium chloride) and FDA (sodium chloride)

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