💊 Drugs • 11,927 recalls
Northern VA Compounders PLLC
Lack of Assurance of Sterility
Lack of assurance of sterility: Bags have the potential to leak.
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Jubilant Cadista Pharmaceuticals
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Hikma Pharmaceuticals USA
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Lupin Pharmaceuticals
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Presence of foreign substance
Aurolife Pharma
Failed Impurities/Degradation Specifications
Lupin Pharmaceuticals
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Underfilled units.
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Fresenius Medical Care Holdings
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Lack of sterility assurance: Bags have the potential to leak.
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.