Class II · Moderate risk
Morbillinum
cGMP deviations
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Medorrhinum
cGMP deviations
Class II · Moderate risk
Influenzinum
cGMP deviations
Class II · Moderate risk
Diphtherinum
cGMP deviations
Class II · Moderate risk
Colibacillinum
cGMP deviations
Class II · Moderate risk
Candida Parapsilosis
cGMP deviations
Class II · Moderate risk
Candida Albicans
cGMP deviations
Class II · Moderate risk
Bacillinum Pulmo
cGMP deviations
Class II · Moderate risk
Anthracinum
cGMP deviations
Class III · Low risk
Tivicay (dolutegravir)
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Class II · Moderate risk
Zonisamide Capsules USP
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class I · High risk
Anagrelide Capsules USP
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Class II · Moderate risk
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II · Moderate risk
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II · Moderate risk
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits