Prescription and over-the-counter medications
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Subpotent Drug
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Lack of Assurance of Sterility
Avantor Performance Materials
Subpotent drug
Lack of Assurance of Sterility
Xiamen Kang Zhongyuan Biotechnology Co.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Owen Biosciences
Chemical contamination: Presence of benzene
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Failed Stability Specifications
Xiamen Kang Zhongyuan Biotechnology Co.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lack of Assurance of Sterility
Xiamen Kang Zhongyuan Biotechnology Co.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Fagron Compounding Services
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: use of an unapproved raw material
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: use of an unapproved raw material
Fagron Compounding Services
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port