TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK…
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Reason Presence of foreign substance
Reason Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Reason Underfilled units.
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Reason Lack of sterility assurance: Bags have the potential to leak.
Reason Subpotent Drug
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Reason Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Reason Failed dissolution specifications
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…
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Reason Failed Impurities/Degradation Specifications