Class III · Low risk Ongoing
Nilotinib Capsules
Reason Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
FDA Drug Recalls
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Class III · Low risk Ongoing
Nilotinib Capsules
Reason Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class II · Moderate risk Ongoing
Midodrine Hydrochloride Tablets
Reason Defective container; inadequately sealed blister packaging.
Class II · Moderate risk Ongoing
Semaglutide
Reason CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Class II · Moderate risk Ongoing
Semaglutide
Reason CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Class II · Moderate risk Ongoing
Amantadine HCl
Reason Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class III · Low risk Ongoing
Eptifibatide Injection
Reason Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Class II · Moderate risk Ongoing
Adbry
Reason Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Class II · Moderate risk Ongoing
Cetrorelix Acetate for Injection
Reason Defective Delivery System: Missing or duplicated needles within the injection kit
Class II · Moderate risk Ongoing
vancomycin HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
vancomycin HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
thiamine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
ketamine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
acyclovir sodium
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexamethasone Sodium Phosphate Injection
Reason Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Class II · Moderate risk Ongoing
Pro Numb Tattoo Numbing Spray
Reason cGMP deviations
Class II · Moderate risk Ongoing
Pro Numb Tattoo Numbing Spray
Reason cGMP deviations
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Diclofenac Sodium
Reason Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Class II · Moderate risk Ongoing
Sodium Iodide
Reason Presence of Particulate Matter: Due to production issues
Class II · Moderate risk Ongoing
Testosterone 100mg Anastrozole 4mg
Reason Presence of Foreign substance - potential presence of metal particulate matter