EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYST… Recalled: Lack of Assurance of Sterility
Lack of Assurance of Sterility
Searching CPSC consumer products, FDA food & drug enforcement reports, and USDA meat & poultry recalls — sorted newest first.
1,498 recalls found — page 37 of 63.
Lack of Assurance of Sterility
Failed Stability Specifications
Subpotent drug
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
The recalled plastic tip restraint kits (also referred to as furniture straps) can break or degrade, posing tip-over and entrapment hazards that can result in serious injuries or death to children or elderly consumers interacting with furniture that is secured to the wall with the defective plastic tip restraints. This is a hidden defect because consumers who purchase and install this product may be under a false sense of security that their furniture is safe from a tip-over incident.
The recalled convertible bassinets violate the mandatory standard for bedside sleepers because the mechanism used to attach the product to the adult bed creates an opening between the bedside sleeper and mattress, posing a deadly fall hazard to infants.
The power strips do not contain supplementary overcurrent protection, which creates a risk of fire if the power strips are overloaded. The resulting fire can cause serious injury or death from smoke inhalation and burns.
Electrical conductors within the sauna heater kits can overheat, posing a fire hazard and risk of serious injury or death.
The recalled DuraTrac gas connectors contain a manufacturing defect that could cause a gas leak, posing a fire hazard to consumers.
The truck's circuit board can overheat and ignite, posing fire and burn hazards.
The magnet ball toys violate the mandatory standard for toys because they are high-powered 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 recalled bed rails violate the mandatory standard for adult portable bed rails because 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.
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
The ice axe shaft can break at the handle during use, posing a fall hazard, which can result in serious injury or death.
The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because the lights contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the screw used on the remote controls to secure the battery compartments that contain a lithium coin battery does not remain attached. Also, the packaging does not have the warnings as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
When the recalled 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. This poses a serious entrapment hazard and risk of death by asphyxiation.
Product may contain foreign objects, specifically glass.
Undeclared allergen (almond).
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40