ChemLifeIntel/Companies/RemedyRepack Inc.

RemedyRepack Inc.

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INTELLIGENCE

Showing 3 of 3 briefs on RemedyRepack Inc.

REGULATORY INTELLIGENCE·Warning Letter

RemedyRepack Inc. Initiates Class II Recall of Duloxetine Capsules Due to Nitrosamine Impurity and CGMP Deviations

RemedyRepack Inc. has initiated a nationwide Class II recall for Duloxetine Delayed-Release Capsules, 60 mg, due to N-nitroso-duloxetine impurity exceeding interim limits and Current Good Manufacturing Practice (CGMP) deviations. This event, following prior recalls, signals escalating compliance risks for procurement and regulatory affairs teams sourcing from RemedyRepack Inc.

90-Day Activity

RemedyRepackDuloxetine Hydrochloride

PSPriya Subramaniam· Intelligence Analyst

2025-01-01 Warning Letter

REGULATORY INTELLIGENCE·Recall

FDA Class II Recall: RemedyRepack's Potassium Chloride Capsules Fail Dissolution Specifications

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.

90-Day Activity

RemedyRepackPotassium Iodide

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2024-07-24

REGULATORY INTELLIGENCE·Warning Letter

FDA Class II Recall: RemedyRepack's TraMADol HCl Contamination Exposes Critical Repackaging Risks

RemedyRepack Inc.'s Class II recall of 23,970 TraMADol HCl 50 mg tablets due to baclofen contamination highlights severe quality control deficiencies in pharmaceutical repackaging. This incident, coupled with a prior recall for dissolution failure, necessitates immediate review of supplier qualification processes by procurement directors and supply chain VPs to mitigate significant patient safety and business risks.

90-Day Activity

RemedyRepackTramadol

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2024-05-15 Warning Letter