Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class I · High risk Terminated
Iohexol
Reason Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class II · Moderate risk Terminated
Oxcarbazepine Tablets 600mg
Reason Presence of foreign substance
Class I · High risk Terminated
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Reason Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class II · Moderate risk Terminated
FentaNYL Citrate 2.5 mg/50 mL
Reason Underfilled units.
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container…
Reason Lack of sterility assurance: Bags have the potential to leak.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets 0.2mg
Reason Subpotent Drug
Class II · Moderate risk Terminated
Sensorcaine-MPF
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk Terminated
Sensorcaine
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk Terminated
Sensorcaine
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class III · Low risk Terminated
Allergy Relief D
Reason Failed dissolution specifications
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Class III · Low risk Terminated
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class III · Low risk Terminated
Phenytoin Sodium Injection
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk Terminated
Phenytoin Sodium Injection
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class II · Moderate risk Terminated
PF-Neostigmine Methylsulfate Injection
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk Terminated
PF-Labetalol HCl Injection
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk Terminated
Phenoxybenzamine Hydrochloride Capsules
Reason Failed Impurities/Degradation Specifications