Ohio recalls

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

Undeclared melatonin.

Firm observed oily and sticky substance on direct food contact surface packaging of finished product.

Undeclared Allergen (Soy)

The product contains unapproved colors chlorophyll E140 and E141.

The product contains unapproved colors chlorophyll E140 and E141.

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

Failed Dissolution Specifications

Labeling: Incorrect or Missing Lot and/or Exp Date