Little Moon Essentials, Aching Head Rub recall — FDA D-0573-2024
CGMP deviations
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
CGMP deviations
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
CGMP deviations
CGMP deviations
CGMP deviations
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
CGMP deviations
CGMP deviations
CGMP deviations
CGMP deviations
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for coils to heat up and harm patients (burn).
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Browse recent months with enough recall history for useful comparison.