Class II · Moderate risk
rocuronium
Lack of assurance of sterility:
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Class II · Moderate risk
PHENYLephrine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
lidocaine 2%
Lack of assurance of sterility:
Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
ketamine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
fentaNYL in 0.9% sodium chloride
Lack of assurance of sterility:
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
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.
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 II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
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 II · Moderate risk
Sucralfate Oral Suspension 1g per 10mL
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
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 I · High risk
WEFUN Capsules 825 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class I · High risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Doxil (doxorubicin hydrochloride liposome injection)
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: slow leakage under the cap
Class II · Moderate risk
Florbetaben F-18
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles