Application ID: # 206814
Product Quantity: 40 mEq/15 mL
Bottle Count: 473 mL bottle
New and improved formulation of Potassium Chloride Oral Solution, USP, 20 mEq/15 ml and 40 mEq/15 ml was approved by FDA in May 2019 and shipments began in July 2019. Due to changes in inactive ingredients a new formulation may appear lighter in color and lighter on taste. However, the new formulation meets the same specifications and has the same purity, potency, and safety standards as the old formulation. The first lot of Potassium Chloride Oral Solution USP, 40 mEq/15 mL is Lot number 32401419A. The first lot of Potassium Chloride Oral Solution USP, 20 mEq/15 mL is lot number 32301719A. Later lots of the same product can be identified by examining the lot numbers, which begin with the same four digits, and the last two digits represent the year (19 being 2019, 20 being 2020). Thus, any lot code ending in 20, and any lot code ending in 19 that is higher than 32401419A or 32301719A were or will be manufactured with the new formulation. PCS-31-083 rev. 3/2020