FDA (Drugs) recall action 92707

Central Admixture Pharmacy Services, Inc. recalled 95 products on 2023-08-09

The FDA (Drugs) publishes a recall like this one as 95 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 95 pages.

Products: 95
Announced: 2023-08-09
Critical: 0
Units: 957,396

Why these products were recalled

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–50 of 95

HighFDA (Drugs)··2023-08-09
FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance
The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.
Product
CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services has recalled 80 bags of Cardioplegia Solution (NDC 72196-0210-1) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1
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HighFDA (Drugs)··2023-08-09
NORepinephrine IV Bags Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling NORepinephrine 4 mg/250 mL IV bags due to lack of sterility assurance caused by insufficient validation of decontamination cycles. The affected lots were distributed nationwide.
Product
NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services is recalling 356 neonatal TPN starter bags due to lack of validation data for decontamination cycles. The sterility of the affected lots cannot be assured.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
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HighFDA (Drugs)··2023-08-09
Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 6,772 bags of vancomycin IV solution nationwide due to lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product
vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution IV bags recalled for missing sterility validation
Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-252142) nationwide because decontamination validation data is lacking, preventing assurance of sterility.
Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
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HighFDA (Drugs)··2023-08-09
IV Transplant Solution Recalled Due to Inadequate Sterilization Validation
Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.
Product
TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
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HighFDA (Drugs)··2023-08-09
PHENYLephrine Injectable Syringe Recall Due to Insufficient Sterility Assurance
Central Admixture Pharmacy Services recalls 499,304 PHENYLephrine syringes nationwide because validation data for sterility decontamination cycles was lacking. No illnesses have been reported.
Product
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
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HighFDA (Drugs)··2023-08-09
Glycopyrrolate Injectable for Anesthesia Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 770 syringes of glycopyrrolate injectable medication nationwide due to lack of validation data for sterilization processes. The product may not meet required sterility standards for safe anesthesia use.
Product
glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN IV bags recalled due to sterility validation deficiency
Central Admixture Pharmacy Services is recalling 24 neonatal TPN IV bags due to lack of sterility assurance. Validation data for decontamination cycles is lacking, preventing confirmation that units are sterile.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0425-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN IV Bags Recalled Over Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 304 neonatal TPN IV starter bags nationwide due to lack of sterility assurance and insufficient validation of decontamination processes. No illnesses have been reported.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Deficiency
Central Admixture Pharmacy Services is recalling 80 bags of Neonatal TPN Starter Bag nationwide due to insufficient sterility assurance. The deficiency stems from lacking validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0402-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 128 neonatal TPN starter bags distributed nationwide due to lacking validation of decontamination procedures, creating inability to assure product sterility.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0400-1
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HighFDA (Drugs)··2023-08-09
Heparin IV bags recalled for lack of validated sterility assurance
Central Admixture Pharmacy Services is recalling 7,509 heparin IV bags nationwide because the company lacks validation data showing the sterilization process works. No illnesses have been reported.
Product
heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
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HighFDA (Drugs)··2023-08-09
EPINEPHrine IV Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services, Inc. is recalling EPINEPHrine 8mg/250ml IV bags due to lack of sterility assurance and insufficient validation data for decontamination cycles. The recall affects 4,570 units distributed nationwide.
Product
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
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HighFDA (Drugs)··2023-08-09
FDA Recalls Neonatal TPN Bags for Inadequate Sterility Validation
Central Admixture Pharmacy Services is recalling 192 bags of Neonatal TPN Starter Bag distributed nationwide due to lack of sterilization validation. The company cannot assure the product's sterility.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0408-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN Starter Bags Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 108 Neonatal TPN Starter Bags (Lot 36-256338) due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
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HighFDA (Drugs)··2023-08-09
Heparin intravenous bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.
Product
heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
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HighFDA (Drugs)··2023-08-09
Heparin IV Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling heparin IV bags due to lack of sterility assurance and missing validation data for decontamination cycles. The recall affects 358 bags distributed nationwide.
Product
heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8000-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution IV Bags Recalled for Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-257024) due to lack of sterility assurance and insufficient validation of decontamination processes. Healthcare providers should discontinue use immediately.
Product
CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0216-1
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HighFDA (Drugs)··2023-08-09
Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 224 neonatal TPN starter bags (250mL IV bags) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
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
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HighFDA (Drugs)··2023-08-09
FDA Recalls Oxytocin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,821 bags of oxytocin IV bags nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
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HighFDA (Drugs)··2023-08-09
IV Oxytocin Solution Recall Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 9,504 IV bags of oxytocin mixed with Lactated Ringer's solution because validation data for sterilization cycles is lacking. The product was distributed nationwide.
Product
oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1
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