Class II · Moderate risk
Influenzinum
cGMP deviations
FDA Drug Recalls
1,206 recalls · Class II, newest first
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 II · Moderate risk
Zonisamide Capsules USP
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk
Alcohol Antiseptic 80%
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
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 II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Lack of assurance of sterility.
Class II · Moderate risk
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Lack of assurance of sterility.
Class II · Moderate risk
Pyridoxine HCL 100 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Phenylephrine 1 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
PGE-3 Alprostadil 150 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Ondansetron Hydrochloride
Lack of assurance of sterility.
Class II · Moderate risk
Olympia Vita-Complex Thiamine HCL
Lack of assurance of sterility.
Class II · Moderate risk
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1…
Lack of assurance of sterility.
Class II · Moderate risk
NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide
Lack of assurance of sterility.
Class II · Moderate risk
Myers Cocktail
Lack of assurance of sterility.