Class I - Dangerous
Subpotent Drug: Flurandrenolide is subpotent.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90
Actavis Laboratories, FL
Class I - Dangerous
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class I - Dangerous
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Class I - Dangerous
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Central Admixture Pharmacy Services
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I - Dangerous
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Central Admixture Pharmacy Services
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I - Dangerous
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Central Admixture Pharmacy Services
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I - Dangerous
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate 4.8mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Central Admixture Pharmacy Services
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Central Admixture Pharmacy Services
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Central Admixture Pharmacy Services
Class I - Dangerous
Non-Sterility: Out of specification results for the sterility test for microbial contamination.