Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Drug Recalls
170 recalls · Class III, newest first
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets USP
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Levocarnitine Injection
Labeling: Missing Label
Class III · Low risk
Premier
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
Class III · Low risk
Lidocaine Wound Gel
Failed PH Specifications
Class III · Low risk
Magnesium Chloride
Subpotent drug
Class III · Low risk
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit
Failed Tablet/Capsule Specifications
Class III · Low risk
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class III · Low risk
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class III · Low risk
Eptifibatide Injection
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 III · Low risk
Pitavastatin Tablets
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Class III · Low risk
Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Class III · Low risk
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class III · Low risk
parodontax
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Class III · Low risk
Diclofenac Sodium Topical Gel
Failed PH Specifications
Class III · Low risk
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III · Low risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class III · Low risk
Clindamycin Phosphate USP
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.