Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
Labeling: Illegible label. Writing is rubbing off of labels.
FDA Drug Recalls
1,711 recalls, newest first
Class II · Moderate risk
Vancomycin Hydrochloride Capsules
Subpotent Drug
Class II · Moderate risk
Mafenide Acetate
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Class II · Moderate risk
Dextroamphetamine Sulfate Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Antacid Liquid Regular Strength Antacid & Anti-Gas
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Fentanyl Citrate
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Morphine Sulfate
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Bupivacaine HCl 0.0625%
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class II · Moderate risk
Erythromycin Pledgets USP
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Class II · Moderate risk
Compounded Plaquex
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class I · High risk
iNSANE Bee Pollen capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
Class I · High risk
BtRiM Max capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.
Class I · High risk
AMPD GOLD Bee Pollen capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
Class I · High risk
iNDiGO capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Class I · High risk
EDGE Amplified Weight Release capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
Class III · Low risk
Nicardipine Hydrochloride Injection
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.