Missouri recalls

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

CGMP Deviations

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Defective Container - A defect in the side-seal which allows leakage of product.

Failed Stability Specifications: Observed OOS results: eg results for colour index

The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.

The chip breaker can contact the cutterhead blades during use, which can cause debris to be ejected from the planer, posing impact and laceration hazards to the user and bystander.

The building toy sets violate the mandatory safety standard because the battery compartment within the LED light piece contains button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled crib bumpers violate the federal crib bumper ban because they can obstruct an infant's breathing, posing a risk of serious injury or death, due to suffocation. This creates an unsafe sleeping environment for infants. Padded crib bumpers are banned by the Safe Sleep for Babies Act.

The recalled toys violate the mandatory standard for toys because the screw used to secure the battery compartment that contains a button cell battery does not remain attached as required. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.

The rivets on the handle can come loose, causing the handle to detach, posing a choking hazard for children.

The recalled magnetic building cubes contain magnets that can become loose if the seams separate, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.

The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in a risk of serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

During assembly or disassembly, the 215-pound frame of the wall bed can fall onto consumers, posing deadly impact, crush, and laceration hazards.

Product testing did not meet expected stability criteria.

Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.