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
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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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
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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 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
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
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 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
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
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
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
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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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
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
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.
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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 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 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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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 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.
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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
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
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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
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
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