Class III · Low risk
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
FDA Drug Recalls
88 recalls · Class III, newest first
Class III · Low risk
Eligard (leuprolide acetate)
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class III · Low risk
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Incorrect/Undeclared Excipients.
Class III · Low risk
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class III · Low risk
Clearasil Rapid Rescue Deep Treatment Pads
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: slow leakage under the cap
Class III · Low risk
Sabril (vigabatrin)
Cross contamination with other products
Class III · Low risk
Nexlizet (bempedoic acid and ezetimibe)
Failed dissolution specifications: below specification results at stability 12-month
Class III · Low risk
Milrinone Lactate Injection
Failed Impurities/Degradation Specifications
Class III · Low risk
Bendamustine HCl Injection
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class III · Low risk
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class III · Low risk
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class III · Low risk
Pluvicto 1
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Class III · Low risk
0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Class III · Low risk
Tobramycin Opthalmic Solution USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Fosfomycin Tromethamine Granules for Oral Solution
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Class III · Low risk
Loteprednol Etabonate Ophthalmic Suspension
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class III · Low risk
Amlodipine Besylate Tablets
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class III · Low risk
PANCREAZE (pancrelipase)
Failed Stability Specifications
Class III · Low risk
Tranexamic Acid USP Tablets
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Lysteda (tranexamic acid)
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Glycopyrrolate Injection
Labeling: Label Mix-up
Class III · Low risk
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride