Consumer Product Recalls

Hazard: Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

Hazard: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Hazard: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Hazard: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Hazard: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Hazard: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Hazard: Failed Dissolution Specifications: low dissolution results

Hazard: Subpotent drug

Hazard: A loose steering coupling can cause a loss of steering control, increasing the risk of a crash.

Hazard: A loss of power brake assist can extend the distance required to stop the vehicle, increasing the risk of a crash.

Hazard: Engine failure increases the risk of a crash.

Hazard: An incorrect warning light can fail to alert the driver to critical safety information, increasing the risk of a crash.

Hazard: A front bumper that detaches can become a road hazard and increase the risk of a crash. In addition, the bolts can fail suddenly during winch operation, increasing the risk of injury.

Hazard: Unvented carbon monoxide increases the risk of injury or death from carbon monoxide poisoning.

Hazard: A TPMS warning light that fails to notify the driver of a problem increases the risk of a crash.

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

Hazard: The LED module can overheat, causing it to melt, posing a fire hazard.

Hazard: The recalled Drinkmate 1L Carbonation Bottles can explode during use, posing serious impact, laceration and hearing damage hazards to users and bystanders.

Hazard: The recalled Safe & Green 32 oz. fuel bottles contain hydrocarbons, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The product includes a nozzle applicator which is not child-resistant, violating the mandatory standard. When the applicator is used instead of the child-resistant closure, it poses a deadly poisoning hazard to young children. Hydrocarbons can get into the lungs, causing chemical pneumonia and pulmonary damage, which can be fatal. In addition, the torch fuel violates the Federal Hazardous Substances Act because it is incorrectly labeled as "Non-Toxic".

Hazard: The recalled toy contains small balls and is intended for children under three years of age, which violates the small ball ban, posing a deadly choking hazard.

Hazard: The kettle's infuser basket lid is loose and can fall off during use, posing a burn hazard to consumers.

Hazard: The ladders' locking mechanism can jam and not fully lock into place, posing a fall hazard.

Hazard: 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.

Hazard: Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.

Hazard: Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

Hazard: Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

Hazard: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)

Hazard: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.

Hazard: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.