Class II · Moderate risk Ongoing
AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
AMBI Skincare Fade Cream Oily Skin New & Improved
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
AMBI Skincare Fade Cream Normal Skin
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Terminated
Vaccinotoxinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Tuberculinum Bovinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Tuberculinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Syphilinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Streptococcinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Pyrogenium
Reason cGMP deviations
Class II · Moderate risk Terminated
Proteus
Reason cGMP deviations
Class II · Moderate risk Terminated
Pertussinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Morbillinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Medorrhinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Influenzinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Diphtherinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Colibacillinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Candida Parapsilosis
Reason cGMP deviations
Class II · Moderate risk Terminated
Candida Albicans
Reason cGMP deviations
Class II · Moderate risk Terminated
Bacillinum Pulmo
Reason cGMP deviations
Class II · Moderate risk Terminated
Anthracinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Zonisamide Capsules USP
Reason CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk Ongoing
Alcohol Antiseptic 80%
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II · Moderate risk Terminated
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .