Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Amitiza
Reason Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class II · Moderate risk Terminated
Amitiza
Reason Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class II · Moderate risk Terminated
Anastrozole Tablets
Reason GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk Terminated
Anastrozole Tablets
Reason GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
MethylPREDNISolone Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 1 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.5 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.25 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochoride Tablets 0.25 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole DihydrochlorideTablets 0.125 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Anastrozole Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
ANASTROZOLE Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Senna
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk Terminated
Senna
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk Terminated
Bevacizumab 2.5 mg/0.1 mL
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx…
Reason 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
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx…
Reason 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
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 50 mg 90 film coated tablets…
Reason 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