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KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow Supply Disruption — Tailstorm Health INC (Moderate

KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow Supply Disruption — Tailstorm Health INC (Moderate is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow; Manufacturer: Tailst

Drug nameKETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow
ManufacturerTailstorm Health INC
Recall/Disruption reasonLack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Risk classificationModerate Risk — Temporary Health Consequence
StatusOngoing
Record typeEnforcement/Recall
Recall numberD-0500-2025
Initiation date20250602
Quantity affected23,200 vials
Dosage formDrugs

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