The Recall Desk

FDA (Drugs) recall action 92898

Central Admixture Pharmacy Services, Inc. recalled 32 products on 2023-09-06

The FDA (Drugs) publishes a recall like this one as 32 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 32 pages.

Products
32
Announced
2023-09-06
Critical
0
Units
19,843

Why these products were recalled

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

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.

1–25 of 32

  • HighFDA (Drugs)··2023-09-06

    Neonatal TPN Starter Bag recalled for sterility assurance concerns

    Central Admixture Pharmacy Services is recalling a neonatal TPN bag due to lack of validated sanitation cycles, affecting 84 units distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
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  • HighFDA (Drugs)··2023-09-06

    Vancomycin Injectable Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling vancomycin injections nationwide (477 bags, lots 36-262215 and 36-262216) due to lack of validation data for sanitization cycles, which prevents assurance of product sterility.

    Product
    vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
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  • HighFDA (Drugs)··2023-09-06

    Neonatal TPN IV bags recalled due to lack of sterility validation

    Central Admixture Pharmacy Services is recalling 200 neonatal TPN IV bags (lots 36-262872 and 36-262873, expiring 8/27/2023) distributed nationwide due to lack of validated sanitization procedures.

    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)··2023-09-06

    Neonatal Injectable Nutrition Bags Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 132 bags of neonatal injectable nutrition due to unvalidated sterilization processes. The lack of sterility assurance creates potential infection risk for neonatal patients receiving these products.

    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)··2023-09-06

    OxyTOCIN IV Bags Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.

    Product
    oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
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  • HighFDA (Drugs)··2023-09-06

    Injectable Oxytocin Recalled Due to Unvalidated Sterilization Process

    Central Admixture Pharmacy Services recalls oxytocin IV bags due to inadequate validation of sterilization, raising sterility concerns for this injectable.

    Product
    oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
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  • HighFDA (Drugs)··2023-09-06

    FDA Recalls Heparin IV Bags Due to Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 577 bags of heparin IV solution (2500 units/500mL) nationwide due to lack of validation data for sanitization cycles, which could compromise sterility assurance.

    Product
    heparin added to 0.9% sodium chloride, 2500 units/500mL (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)··2023-09-06

    FDA Recalls EPINEPHrine IV Bags for Unvalidated Sterilization Processes

    Central Admixture Pharmacy Services is recalling 340 bags of epinephrine IV solution due to inadequate validation of sterilization procedures, creating a potential contamination risk.

    Product
    EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
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  • HighFDA (Drugs)··2023-09-06

    Neonatal TPN Starter Bags Recalled for Insufficient Sterilization Validation

    Central Admixture Pharmacy Services is recalling 136 neonatal TPN starter bags due to lack of validated sterilization cycles. The recall affects bags distributed nationwide with lot numbers 36-262160 and 36-262146.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/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: 72196-0428-1
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  • HighFDA (Drugs)··2023-09-06

    Neonatal TPN Starter Bag Recalled Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 104 neonatal TPN starter bags (Lot 36-260022) due to lack of validation data for sanitization cycles, which could compromise sterility assurance in this IV medication.

    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)··2023-09-06

    Rocuronium Injectable Drug Recalled Due to Sterility Assurance Failure

    The FDA is recalling rocuronium injectable syringes due to unvalidated sterilization processes. The product was distributed nationwide.

    Product
    rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
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  • HighFDA (Drugs)··2023-09-06

    Neonatal TPN IV Bags Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 92 bags of neonatal TPN IV bags (lot 36-262161) because of inadequate validation of manufacturing sanitization processes. The affected product was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
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  • HighFDA (Drugs)··2023-09-06

    Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls Cardioplegia Solution due to inadequate validation of sterilization processes. One lot (36-262881) distributed nationwide may not be assured sterile.

    Product
    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
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  • HighFDA (Drugs)··2023-09-06

    Diltiazem IV Bag Recalled Due to Lack of Sterilization Assurance

    Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
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  • HighFDA (Drugs)··2023-09-06

    Neonatal TPN Nutrition Bags Recalled for Sterility Validation Deficiency

    Central Admixture Pharmacy Services recalled 108 bags of neonatal TPN solution (Lot 36-260017, expires 8/19/2023) due to insufficient validation data for sterilization cycles. The product was 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)··2023-09-06

    FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.

    Product
    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
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  • HighFDA (Drugs)··2023-09-06

    Cardioplegia Solution Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.

    Product
    Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture…
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  • HighFDA (Drugs)··2023-09-06

    Phenylephrine IV Bags Recalled for Sterility Assurance Deficiency

    Central Admixture Pharmacy Services recalls 297 bags of phenylephrine IV solution due to lack of validated sanitization procedures. The Class II recall affects nationwide distribution.

    Product
    PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
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  • HighFDA (Drugs)··2023-09-06

    FDA Recalls Phenylephrine IV Bags Due to Unvalidated Sanitization

    Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.

    Product
    PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1
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  • HighFDA (Drugs)··2023-09-06

    dilTIAZem IV Bags Recalled Due to Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.

    Product
    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
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  • HighFDA (Drugs)··2023-09-06

    Neonatal Intravenous Nutrition Bags Recalled for Insufficient Sterility Validation

    Central Admixture Pharmacy Services recalled 40 bags of Neonatal TPN starter bags due to lack of validation data for sanitization cycles. This creates a potential sterility assurance gap for an intravenous medication used for newborns.

    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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    0 states
  • HighFDA (Drugs)··2023-09-06

    Epinephrine IV Bags Recalled Due to Lack of Sanitization Validation

    Central Admixture Pharmacy Services is recalling epinephrine IV bags (Lot 36-260047) because sanitization processes lacked adequate validation data. The manufacturer cannot confirm the product meets sterility standards required for injectable medications.

    Product
    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.
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    0 states
  • HighFDA (Drugs)··2023-09-06

    Cardioplegia Solution Recalled for Unvalidated Sterilization Process

    Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.

    Product
    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
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  • HighFDA (Drugs)··2023-09-06

    Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot #36-262515) due to lack of validation data for sanitization cycles, creating uncertainty about sterility standards for this injectable product.

    Product
    CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
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  • HighFDA (Drugs)··2023-09-06

    Phenylephrine IV Injection Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls phenylephrine IV bags nationwide because the manufacturer lacks validated sanitization data to ensure sterility. Healthcare providers should identify and quarantine affected inventory.

    Product
    PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
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