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

    EPINEPHrine IV bags recalled for sterility assurance failure

    Central Admixture Pharmacy Services recalled 554 bags of EPINEPHrine added to dextrose 5% IV bags nationwide due to insufficient validation of sanitization procedures, creating a lack of sterility assurance.

    Product
    EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-09-06

    Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.

    Product
    PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-09-06

    FDA Recalls Phenylephrine IV Bags Due to Sterility Validation Concerns

    Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.

    Product
    PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
    Category
    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 lack of validation data for sanitization cycles, which cannot assure product sterility.

    Product
    CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-09-06

    Sterile Injectable Drug Recall: oxyTOCIN in Lactated Ringer's IV Bags

    Central Admixture Pharmacy Services is recalling 1,996 bags of oxyTOCIN in Lactated Ringer's IV bags because the company cannot assure the products are sterile. The firm lacks validation data for its sanitization procedures.

    Product
    oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
    Category
    Distribution
    0 states