Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Prescription Drugs
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Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Penicillin Cross Contamination
Penicillin Cross Contamination
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02
Pharmakon Pharmaceuticals
Lack of Assurance of Sterility
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
Pharmakon Pharmaceuticals
Lack of Assurance of Sterility
Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02
Pharmakon Pharmaceuticals
Lack of Assurance of Sterility
Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02
Pharmakon Pharmaceuticals
Lack of Assurance of Sterility
Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75
Pharmakon Pharmaceuticals
Lack of Assurance of Sterility
Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70
Pharmakon Pharmaceuticals
Lack of Assurance of Sterility
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.