Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion
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OII Vibrant K9. Oak Hills, CA. Sample Analysis issued 03/23/2020
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 03/23/2020
Short Title (70 char) Vibrant K9. Oak Hills, CA. Sample Analysis issued 03/23/2020
FEI Number 3016619230
Firm Name Vibrant K9
Record Type Sample Analysis
State CA
Establishment Type Pet Food Manufactu
Record Date 03/23/2020
Short Title (70 char) Vibrant K9. Oak Hills, CA. Sample Analysis issued 03/23/2020
FEI Number 3016619230
Firm Name Vibrant K9
Record Type Sample Analysis
State CA
Establishment Type Pet Food Manufactu
FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
Anesthesia Breathing Circuit Kit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit Kits Due to Cracks in Hose That May Cause Inadequate Ventilation
Breathing circuits may develop cracks during use, potentially causing ventilation leaks that can result in hypoxia or hypercarbia.