Class II · Moderate risk Terminated
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Premium Nature Instant Hand Sanitizer
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Completed
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Pyridoxine HCL 100 mg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Phenylephrine 1 mg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
PGE-3 Alprostadil 150 mcg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Ondansetron Hydrochloride
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Olympia Vita-Complex Thiamine HCL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
NAD+ Nicotinamide Adenine Dinucleotide
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Myers Cocktail
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Micc
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Methylcobalamin 5 mg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Magnesium Chloride
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Lipo-Mino-Mix Pyridoxine HCL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Lidocaine 1%/Epinephrine 1:100
Reason Lack of assurance of sterility.