Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP
Reason Defective Container: slow leakage under the cap
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Completed
Sabril
Reason Cross contamination with other products
Class III · Low risk Completed
Nexlizet
Reason Failed dissolution specifications: below specification results at stability 12-month
Class III · Low risk Terminated
Milrinone Lactate Injection
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Completed
Bendamustine HCl Injection
Reason Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class III · Low risk Ongoing
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg
Reason Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class III · Low risk Terminated
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%
Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class III · Low risk Terminated
Pluvicto 1
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Class III · Low risk Terminated
0.9% Sodium Chloride Injection USP
Reason Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Class III · Low risk Ongoing
Tobramycin Opthalmic Solution USP
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Fosfomycin Tromethamine Granules for Oral Solution
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class III · Low risk Terminated
Dofetilide Capsules 500 mcg
Reason Out of Specification result observed in content uniformity testing
Class III · Low risk Terminated
Loteprednol Etabonate Ophthalmic Suspension
Reason Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class III · Low risk Terminated
Amlodipine Besylate Tablets
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class III · Low risk Ongoing
Pancreaze
Reason Failed Stability Specifications
Class III · Low risk Ongoing
Tranexamic Acid USP Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Lysteda
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Glycopyrrolate Injection
Reason Labeling: Label Mix-up
Class III · Low risk Terminated
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Reason Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class III · Low risk Terminated
Glycopyrrolate Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Methylprednisolone Acetate Injectable Suspension
Reason Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert