Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
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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
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Class III · Low risk Terminated
Atropine Sulfate Ophthalmic 1% Solution
Reason Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Class II · Moderate risk Terminated
Labetalol Hydrochloride Injection
Reason Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Class II · Moderate risk Terminated
Vardenafil HCl
Reason cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation USP
Reason Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Class II · Moderate risk Terminated
Vancomycin 1.25g 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
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
PVP Scrub Solution
Reason Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Class I · High risk Terminated
Bella Capsules
Reason Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Class III · Low risk Terminated
Cystaran
Reason Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class II · Moderate risk Terminated
SyrSpend SF Suspending Base
Reason Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Class II · Moderate risk Terminated
Valacyclovir Tablets USP 1 gram
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Class II · Moderate risk Terminated
Valganciclovir Tablets
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Class III · Low risk Terminated
Calcium Acetate Capsules
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Terminated
Acyclovir Tablets
Reason Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Class II · Moderate risk Terminated
Fluticasone propionate USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.