Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60
Contract Pharmaceuticals Limited Canada
Class I - Dangerous
Defective Container: slow leakage under the cap
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
Central Admixture Pharmacy Services
Class I - Dangerous
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP Deviations
Class I - Dangerous
cGMP deviations: Batch was released prior to approval.
Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class I - Dangerous
cGMP deviations: Batch was released prior to approval.
Class I - Dangerous
CGMP Deviations