August 18, 2017
SCA Pharmaceuticals is recalling 2 lots of potassium chloride in sodium chloride because of sterility concerns, according to the August 2, 2017, US Food and Drug Administration (FDA) Enforcement Report.
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The recall spans 2 formulations:
- potassium chloride 20 mEq added to sodium chloride 0.9% 250 mL (NDC 70004-0832-40) from lot 20170501@66 (beyond-use date 7/15/17), and
- potassium chloride 40 mEq added to sodium chloride 0.9% 250 mL (NDC 70004-0833-40) from lot 20170509@10 (beyond-use date 7/23/17).
The affected potassium chloride solution was distributed across the country.
SCA Pharmaceuticals announced the voluntary recall July 14, 2017. The FDA subsequently designated it Class II, suggesting exposure to the affected product could cause temporary or medically reversible health consequences. The likelihood of serious harm is remote, however.
Potassium chloride is used to prevent and treat hypokalemia in adults and children.