South Dakota recalls

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

Failed Dissolution Specifications

Subpotent Drug

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

The handheld hair dryers lack an immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in.

The recalled children's and youth helmets violate the mandatory safety standard for bicycle helmets. Particularly, the helmets do not comply with the positional stability and coverage requirements. The helmets can fail to protect the user in the event of a crash, posing a risk of injury or death due to head injury.

The high chairs violate the mandatory standard for high chairs because they were sold without the required attached restraint system, posing a deadly fall hazard to babies. In addition, a child's head can become trapped in the opening between the seat and tray, posing a deadly entrapment hazard.

The stoves can explode or catch fire, posing a burn and fire hazard to consumers.

The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury.

The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate slat and the side wall, posing a risk of serious injury or death due to entrapment.

The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury.

The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.

The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.

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

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

The recalled magnet spinner sets violate the mandatory standard for toys because the sets contain loose magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they 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 riding mower's steering arm dampers can be installed incorrectly, which can result in an unexpected bouncing motion and loss of operator control, posing a crash hazard.

The ethanol fuel bottles violate the federal safety standard for portable fuel containers because they lack flame mitigation devices required by the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. The fuel containers also fail to meet the federal safety regulation for deceptive disclaimers required by the Federal Hazardous Substances Act (FHSA) because they claim the contents are "Non-Toxic."

The recalled pajama sets violate the mandatory standards for children's sleepwear, posing a risk of serious injuries or deadly burn hazard to children.

The play yards violate the mandatory standard for play yards. Infants can become entrapped under the mattress or between the side of the play yard and the mattress, posing a risk of serious injury or deadly suffocation hazard.

The platform inside the tower can collapse, posing a fall hazard to young children.

The recalled baby loungers violate the mandatory standard for Infant Sleep Products. The sides are too low to contain an infant. The enclosed openings at the foot of the loungers are wider than allowed, posing fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard, if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.

The stroller violates the mandatory standard for strollers because the restraint system can fail, posing a risk of serious injury or deadly fall hazard.

Due to an device without a premarket clearance being incorrectly package and distributed.

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.