FDA is requiring new warnings about the risk of serious breathing difficulties that can lead to death in patients who use gabapentanoids with opioid pain medicines or other drugs that depress the central nervous system.
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Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/04/2025
Short Title (70 char) Qualgen LLC. Edmond, OK. 483 issued 09/04/2025
FEI Number 3011286349
Firm Name Qualgen LLC
Record Type 483
State OK
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