Customceutical Compounding recalls

FDA enforcement reports naming Customceutical Compounding as the recalling firm.

Recall reports: 10
Class I (serious): 0
Most recent report: May 8, 2019

Severity

May 8, 2019BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML)…Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML)…Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019Glutathione 200mg/mL injDrug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compoundedDrug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALA…Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COM…Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COM…Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MUL…Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/m…Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II
May 8, 2019TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0Drug · Customceutical CompoundingLack of assurance of sterility for injectables and solutions intended to be sterile.Class II