All recalls8,501 total
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Out of specification for dissolution.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Products were mislabeled as the 6mm product but included the 5 mm product.
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Hard corn starch lumps were found in the product
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Cyber vulnerability of BLE communication was found by CISA VDP program.
Cyber vulnerability of BLE communication was found by CISA VDP program.
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Incorrect expiration date
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Potential exposure of rodents and rodent activity in the distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.