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
The devices were shipped unsterilized.
The devices were shipped unsterilized.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ethicon Endo-Surgery Inc or your healthcare provider for instructions. Notification method: Letter
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80. Reason: The devices were shipped unsterilized.. Classification: Class II. Quantity: 3 units. Distribution: International distribution to the countries of United Arab Emirates.
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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