Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Sub-potency
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Defective Delivery System: difficult to express
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.