Class II · Moderate risk
Levophed norepinephrine bitartrate
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
Saphris 10 mg
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class II · Moderate risk
PHENYLephrine HCL in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
HYDROmorphone HCL in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
morphine sulfate in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
morphine sulfate in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
Nystatin Topical Powder
Presence of Foreign Substance: potential presence of plastic particles.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Class II · Moderate risk
Milrinone Lactate in 5% Dextrose Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Fluconazole Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Oxygen Refrigerated Liquid USP UN 1073
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class II · Moderate risk
Buprenorphine HCI Injection
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Class II · Moderate risk
Clozapine Tablets USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Amitriptyline HCL Tablets
Labeling: Label Mixup; potentially mislabeled