92,900 total recalls in our database
The Harvard Drug Group LLC
Failed Impurity/Degradation Specifications
The Harvard Drug Group LLC
Failed Impurity/Degradation Specifications
Safecor Health
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health
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
Safecor Health
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.
Safecor Health
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health
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.
Maquet Cardiovascular
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 Healthcare
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 Healthcare
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.