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All product recalls affecting Maryland.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maryland in the distribution area.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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.
International Motors, LLC (International) is recalling certain 2016-2024 IC Bus CESB school buses. The brake pressure switch assembly may leak brake fluid into the brake pressure switch's electrical components and cause an electrical short-circuit.
Potential for undetected, deformed a-traumatic tips.
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.
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
International Motors, LLC (International) is recalling certain 2018 International 4000 Series 4300, 2017-2025 MV, 2018-2024 1300 FBC, 2018-2025 IC Bus TC, and 2024-2025 IC Bus CECB vehicles. The brake pressure switch assembly may leak brake fluid into the brake pressure switch's electrical components and cause an electrical short-circuit.
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Fontaine Modification Company (Fontaine Modification) is recalling certain 2022-2024 Freightliner Business Class M2 vehicles. Welds may crack and fail, allowing the Intermediate steering shaft assembly to detach from the steering column.
The catheters may not retain their shape.
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.