Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Amitiza (lubiprostone)
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
Amitiza (lubiprostone)
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
Anastrozole Tablets
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk
Anastrozole Tablets
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.5 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.25 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochoride Tablets 0.25 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole DihydrochlorideTablets 0.125 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Anastrozole Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
ANASTROZOLE Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Senna (sennosides 8.8 mg)
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk
Senna (sennosides 8.8 mg)
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk
Bevacizumab 2.5 mg/0.1 mL
Lack of assurance of sterility