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Presence of foreign substance
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Underfilled units.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Lack of sterility assurance: Bags have the potential to leak.
Subpotent Drug
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
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.
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Product is sub-potent for Vitamins A, B12, B5 (Pantothenic acid), C, and E not meeting label claims.
CGMP Deviations: Potential for cross contamination due to product carry over.
Failed Impurities/Degradation Specifications