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.

51–75 of 95

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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HighFDA (Drugs)··2023-08-09
FDA Recalls Neostigmine Injectable Syringes Due to Sterility Assurance Deficiency
FDA is recalling Central Admixture Pharmacy Services' neostigmine injectable syringes due to lacking validation data for sterilization decontamination cycles, raising concerns about product sterility.
Product
neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
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HighFDA (Drugs)··2023-08-09
IV Phenylephrine bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalled 9,432 IV bags containing phenylephrine due to lack of assurance of sterility and insufficient validation data for decontamination cycles. The product was distributed nationwide.
Product
PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, 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)··2023-08-09
Succinylcholine Injectable Syringes Recalled for Unvalidated Decontamination Cycles
Central Admixture Pharmacy Services recalls 26,208 succinylcholine injection syringes nationwide due to lack of validated sterilization procedures. The manufacturer lacks adequate validation data for decontamination cycles.
Product
succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
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HighFDA (Drugs)··2023-08-09
Heparin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.
Product
heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
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HighFDA (Drugs)··2023-08-09
Oxytocin IV bags recalled nationwide for insufficient sterility assurance
Central Admixture Pharmacy Services recalled 2,692 bags of oxytocin IV solution nationwide because the company lacks data needed to prove the sterilization process is effective.
Product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
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HighFDA (Drugs)··2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Concerns
Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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: 72196-0430-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia solution IV bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
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HighFDA (Drugs)··2023-08-09
Phenylepherine IV bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.
Product
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, 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)··2023-08-09
Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 2,914 bags of vancomycin IV medication nationwide due to lack of assurance of sterility caused by missing validation data for decontamination cycles.
Product
vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of sterility assurance and missing validation data for manufacturing decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1
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HighFDA (Drugs)··2023-08-09
FDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance
Central Admixture Pharmacy Services recalls 68 neonatal TPN starter bags nationwide due to lack of validation data for decontamination cycles, posing a contamination risk.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% 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: 72196-0427-1
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HighFDA (Drugs)··2023-08-09
Phenylephrine IV bags recalled due to sterility validation gaps
Central Admixture Pharmacy Services has recalled 472 phenylephrine IV bags distributed nationwide due to insufficient validation data for sterilization processes.
Product
phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 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)··2023-08-09
Neonatal TPN Starter Bag Recall Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags because sterility cannot be assured and decontamination cycle validation data is lacking. The affected lot (36-254911) was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution 122 mEq K Recalled for Sterility Failure
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination. The product was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.
Product
CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1
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HighFDA (Drugs)··2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
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HighFDA (Drugs)··2023-08-09
FDA Recalls IV Potassium Phosphate Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 7,469 bags of potassium phosphate IV solution nationwide because decontamination validation data is lacking, creating a sterility assurance gap.
Product
potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
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HighFDA (Drugs)··2023-08-09
Norepinephrine IV bags recalled for sterility validation deficiency
Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was distributed nationwide.
Product
norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
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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
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
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 132 bags of Cardioplegia Solution (Lot 36-254403) nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV 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)··2023-08-09
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
Neonatal TPN starter bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 244 neonatal TPN IV bags due to lack of assurance that the sterility process was validated. The manufacturer lacked adequate validation data for their decontamination cycles.
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)··2023-08-09
Potassium Phosphate IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling potassium phosphate intravenous bags due to lack of sterility assurance and missing validation data for decontamination processes. The recall affects 234 bags distributed nationwide.
Product
potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1
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