Class II · Moderate risk
Nb-243
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
At-1
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
At-6
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Formula F9
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
T-105
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60…
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Sermorelin Acetate
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Travoprost Ophthalmic Solution
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class II · Moderate risk
CBD Metered Dose Inhaler
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Janumet (sitagliptin and metformin HCl)
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class II · Moderate risk
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Preferred Pharmaceuticals
Out of specification results observed in dissolution during long term stability testing.
Class II · Moderate risk
Magnesium Hydroxide 1200mg
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: Failure to properly investigate failed microbial testing.