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.

26–32 of 32

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

    Neonatal TPN Starter Bags Recalled for Sterility Assurance Gaps

    Central Admixture Pharmacy Services is recalling 140 bags of Neonatal TPN Starter Bag due to lack of validation data for sanitization cycles. The injectable nutrition product was distributed nationwide.

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

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.

    Product
    CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
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    Distribution
    0 states