ICU Medical, Inc. has initiated a Class I recall (D-0268-2025) for its Potassium Chloride Injection due to a critical labeling error where 10 mEq overwraps may contain 20 mEq containers. This poses a severe patient safety risk, demanding immediate action from procurement, supply chain, and regulatory teams to assess inventory and ensure compliance.
Amerisource Health Services initiated a Class I recall of 61,231 bottles of Potassium Chloride Extended-Release Capsules due to failed dissolution specifications. Manufactured by Glenmark Pharmaceuticals, this nationwide US recall highlights critical quality control gaps impacting patient safety and supply chain stability. Procurement and regulatory teams must immediately assess inventory and re-evaluate supplier risk.
Glenmark Pharmaceuticals Inc., USA has initiated a Class I recall for 36,630 bottles of Potassium Chloride Extended-Release Capsules, USP, due to failed dissolution specifications. This critical issue, originating from its Indian manufacturing facility, poses significant supply chain risks and demands immediate action from procurement and regulatory teams to ensure patient safety and maintain supply continuity for this essential electrolyte.
RemedyRepack Inc. has initiated a Class II recall for Potassium Chloride Micro 10mEq K Extended Release Capsules due to critical dissolution failures, indicating CGMP deviations. This nationwide recall, impacting 142 blister cards, highlights significant quality control lapses in repackaging operations, demanding immediate review of supplier qualification and quality assurance protocols by procurement and regulatory teams.