Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
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Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
Class III · Low risk Terminated
Triamcinolone Acetonide Lotion
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk Terminated
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal
Reason Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Class I · High risk Terminated
Red Zone Xtreme 3000 Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class II · Moderate risk Terminated
E-Z-Paste Barium Sulfate Esophageal Cream
Reason Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Class III · Low risk Terminated
Clocortolone Pivalate Cream
Reason Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Class II · Moderate risk Terminated
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Sermorelin Acetate
Reason Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk Terminated
Oxytocin USP
Reason Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk Terminated
Morphine Sulfate USP Milled
Reason Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Class III · Low risk Terminated
Decitabine for Injection
Reason Failed impurities/degradation specifications: Failure to water content and impurity
Class III · Low risk Terminated
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Reason Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Class III · Low risk Terminated
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk Terminated
Flucanazole Injection
Reason Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Class II · Moderate risk Terminated
RANITIDINE Tablets
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Evamist
Reason Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Class II · Moderate risk Terminated
Coppertone Kids Sunscreen Spray
Reason Labeling: Label mix-up
Class III · Low risk Terminated
Lynparza
Reason Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Class III · Low risk Terminated
labetalol HCl injection 20 mg/4 mL
Reason Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018