Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Consumers and healthcare providers should stop using this product immediately. Contact IntegraDose Compounding Services LLC or your healthcare provider for guidance. Notification method: Letter
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1. Reason: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.. Classification: Class I. Quantity: 853/500 mL bags. Distribution: Nationwide in the USA
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Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Labeling: Incorrect or Missing Lot and/or Exp Date