All Recalls

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Lack of Sterility Assurance

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury.

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.