Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules USP
Reason Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
methylcobalamin 1mg/1mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Option 2
Reason Defective Container: Carton is missing the tablet blister strip and tablet.
Class II · Moderate risk Terminated
Methocarbamol
Reason CGMP Deviations: Lack of quality assurance at the API manufacturer.
Class II · Moderate risk Terminated
Caffeine Powder
Reason Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk Terminated
Zenatane
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk Terminated
Levophed norepinephrine bitartrate
Reason GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Class II · Moderate risk Terminated
Saphris 10 mg
Reason Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class II · Moderate risk Terminated
PHENYLephrine HCL in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
HYDROmorphone HCL in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
morphine sulfate in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
morphine sulfate in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
Nystatin Topical Powder
Reason Presence of Foreign Substance: potential presence of plastic particles.
Class II · Moderate risk Terminated
Milrinone Lactate in 5% Dextrose Injection
Reason Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk Terminated
Oxygen Refrigerated Liquid USP UN 1073
Reason GMP Deviations: The firm does not include an SOP for testing for out of specifications.