Loading...
Loading...
All product recalls affecting New York.
Includes nationwide recalls (tagged “Nationwide”) and recalls with New York in the distribution area.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Unapproved Drug Claims.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Unapproved Drug Claims.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.