💊 Drugs • 11,927 recalls
Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Failed Dissolution Specifications.
Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Baxter Healthcare
Lack of Assurance of Sterility: Bags have potential to leak.
Failed Dissolution Specifications
Lack of Assurance of Sterility: Bags have the potential to leak.
Labeling: Missing label; Product complaints reported missing bottle label.
Lack of Assurance of Sterility: Bags have the potential to leak.
Presence of Particulate Matter; glass particulates
Teva Pharmaceuticals USA
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.
American Health Packaging
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
First Pharma Associates LLC
Lack of Assurance of Sterility.
MAJOR PHARMACEUTICALS
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
First Pharma Associates LLC
Lack of Assurance of Sterility.
First Pharma Associates LLC
Lack of Assurance of Sterility.