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
Applied Medical Technology recalled 840 NutraGlide Nasal Feeding Tubes on August 12, 2025. The tubes may have distal tips that detach unexpectedly, posing a risk to patients. Healthcare providers and patients must stop using the device immediately and follow recall instructions.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Applied Medical Technology Inc or your healthcare provider for instructions. Notification method: Letter
The recall involves NutraGlide Nasal Feeding Tubes with Stylet and ENFit, measuring 5 F - 8 F x 55. These devices were distributed in Massachusetts and Rhode Island.
The distal tips of the NutraGlide Nasal Feeding Tubes may detach at lower than expected forces. This defect raises the risk of complications during feeding.
There have been no specific reported injuries or deaths associated with this recall. The high hazard classification indicates the potential for serious incidents.
Stop using the recalled nasal feeding tubes immediately. Contact Applied Medical Technology Inc or your healthcare provider for further instructions and follow the recall guidelines.
For assistance, call Applied Medical Technology at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0129-2026.
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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