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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

CAPS IV Bags and Syringes Recalled for Potential Lack of Sterility

Agency Publication Date: August 28, 2023
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Summary

Central Admixture Pharmacy Services, Inc. (CAPS) is recalling 19,843 units of various IV bags and syringes because they may not be sterile. The affected products include various medications such as Epinephrine, Phenylephrine, Oxytocin, Vancomycin, and Neonatal TPN Starter Bags distributed nationwide to hospitals and healthcare facilities. This recall was initiated due to a lack of validation data for sanitization cycles during the manufacturing process. While no injuries or infections have been reported to date, the lack of sterility assurance poses a significant safety risk for patients receiving these intravenous treatments.

Risk

The administration of non-sterile injectable products directly into the bloodstream can lead to serious and potentially life-threatening infections, such as sepsis or meningitis. Because these products are intended for intravenous use in clinical settings, any compromise in sterility increases the risk of systemic infection for vulnerable patients.

What You Should Do

  1. This recall affects various intravenous (IV) bags and syringes produced by Central Admixture Pharmacy Services, Inc. (CAPS), including specialized solutions like Cardioplegia, Neonatal TPN, and medications like Epinephrine and Oxytocin.
  2. Identify if your supply is affected by checking the medication name, National Drug Code (NDC), and lot numbers printed on the bag or syringe label.
  3. Because this recall includes dozens of different medications and over 19,000 units, please see the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled products immediately and quarantine any remaining inventory.
  5. Contact Central Admixture Pharmacy Services, Inc. or your distributor directly to arrange for the return of the products.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and return of hospital-administered medications.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: EPINEPHrine added to dextrose 5% (4mg/250ml)
Variants: 16 mcg/mL, IV Bag
Lot Numbers:
36-262162 (Exp 10/5/2023)
36-262163 (Exp 10/5/2023)
NDC:
72196-7018-1

Quantity: 554 bags

Product: EPINEPHrine added to 0.9% sodium chloride (4mg/250mL)
Variants: 16 mcg/mL, IV Bag
Lot Numbers:
36-260047 (Exp 10/3/2023)
NDC:
72196-8093-1

Quantity: 292 bags

Product: CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium (810 mL)
Variants: EVA Bag
Lot Numbers:
36-262315 (Exp 8/21/2023)
36-262514 (Exp 8/25/2023)
36-262993 (Exp 8/28/2023)
NDC:
72196-0103-1

Quantity: 304 bags

Product: CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM (830 mL)
Variants: EVA Bag
Lot Numbers:
36-262513 (Exp 8/25/2023)
36-262880 (Exp 8/27/2023)
NDC:
72196-0100-1

Quantity: 184

Product: CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine (500 mL)
Variants: EVA Bags
Lot Numbers:
36-262515 (Exp 8/25/2023)
NDC:
72196-0111-1

Quantity: 84 bags

Product: CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium (500 mL)
Variants: EVA Bag
Lot Numbers:
36-262516 (Exp 8/25/2023)
NDC:
72196-0105-1

Quantity: 84 bags

Product: Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte (1047 mL)
Variants: EVA Bag
Lot Numbers:
36-262881 (Exp 8/27/2023)
NDC:
72196-0211-1

Quantity: 100 bags

Product: Cardioplegia Solution del Nido Formula (1,052.8 mL)
Variants: EVA Bag
Lot Numbers:
36-260068 (Exp 8/29/2023)
36-260062 (Exp 8/29/2023)
36-260070 (Exp 8/29/2023)
36-260063 (Exp 8/29/2023)
36-260064 (Exp 8/29/2023)
36-260016 (Exp 9/3/2023)
36-262540 (Exp 9/9/2023)
36-262536 (Exp 9/9/2023)
36-262534 (Exp 9/9/2023)
36-262990 (Exp 9/12/2023)
36-262992 (Exp 9/12/2023)
NDC:
72196-0202-1

Quantity: 786 Bags

Product: rocuronium 50 mg/5 mL (10 mg/mL)
Variants: 5 mL Syringes
Lot Numbers:
36-262729 (Exp 10/11/2023)
36-262982 (Exp 10/11/2023)
36-262981 (Exp 10/11/2023)
36-262732 (Exp 10/11/2023)
36-262731 (Exp 10/11/2023)
36-262730 (Exp 10/11/2023)
NDC:
72196-6010-1

Quantity: 3519 Syringes

Product: Neonatal TPN Starter Bag, Amino Acids 2.5%/Dextrose 10% (250mL)
Variants: with CALCIUM and HEPARIN, EVA Bag
Lot Numbers:
36-260015 (Exp 8/19/2023)
NDC:
72196-0418-1

Quantity: 84 bags

Product: Neonatal TPN Starter Bag, Amino Acids 3% / Dextrose 10% (250mL)
Variants: IV Bag
Lot Numbers:
36-262157 (Exp 8/21/2023)
NDC:
72196-0404-1

Quantity: 40 bags

Product: Neonatal TPN Starter Bag, Amino Acids 3.5%/Dextrose 10% (250mL)
Variants: IV Bag
Lot Numbers:
36-262872 (Exp 8/27/2023)
36-262873 (Exp 8/27/2023)
NDC:
72196-0406-1

Quantity: 200 bags

Product: Neonatal TPN Starter Bag, Amino Acids 3%/Dextrose 5% (250mL)
Variants: with CALCIUM and HEPARIN, IV Bag
Lot Numbers:
36-260022 (Exp 8/19/2023)
NDC:
72196-0419-1

Quantity: 104 bags

Product: Neonatal TPN Starter Bag, Amino Acids 3%/Dextrose 10% (250mL)
Variants: with CALCIUM and HEPARIN, IV Bag
Lot Numbers:
36-260019 (Exp 8/19/2023)
36-260023 (Exp 8/19/2023)
NDC:
72196-0420-1

Quantity: 140 bags

Product: Neonatal TPN Starter Bag, Amino Acids 3%/Dextrose 10% low calcium (250mL)
Variants: with HEPARIN, IV Bag
Lot Numbers:
36-262160 (Exp 8/21/2023)
36-262146 (Exp 8/21/2023)
NDC:
72196-0428-1

Quantity: 136 bags

Product: Neonatal TPN Starter Bag, Amino Acids 3.5% / Dextrose 10% low calcium (250mL)
Variants: with HEPARIN, IV Bag
Lot Numbers:
36-260018 (Exp 8/19/2023)
36-262155 (Exp 8/21/2023)
NDC:
72196-0429-1

Quantity: 132 bags

Product: Neonatal TPN Starter Bag, Amino Acids 3.5%/Dextrose 10% (250mL)
Variants: with HEPARIN, IV Bag
Lot Numbers:
36-262161 (Exp 8/21/2023)
NDC:
72196-0431-1

Quantity: 92 bags

Product: Neonatal TPN Starter Bag, Amino Acids 4%/Dextrose 10% (250mL)
Variants: with CALCIUM and HEPARIN, IV Bags
Lot Numbers:
36-260017 (Exp 8/19/2023)
NDC:
72196-0422-1

Quantity: 108 bags

Product: CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA (572.64 mL)
Variants: IV Bag
Lot Numbers:
36-262542 (Exp 8/25/2023)
NDC:
72196-0217-1

Quantity: 16 bags

Product: PHENYLephrine 1,000 mcg/10mL (100mcg/mL)
Variants: in 0.9% sodium chloride, 10 mL Syringe
Lot Numbers:
36-262312 (Exp 10/5/2023)
36-262314 (Exp 10/5/2023)
36-262311 (Exp 10/5/2023)
36-262313 (Exp 10/5/2023)
36-262739 (Exp 10/11/2023)
36-262742 (Exp 10/11/2023)
36-262741 (Exp 10/11/2023)
36-262740 (Exp 10/11/2023)
36-262738 (Exp 10/11/2023)
36-262737 (Exp 10/11/2023)
NDC:
72196-6009-1

Quantity: 4100 syringes

Product: PHENYLephrine added to 0.9% sodium chloride (10mg/250ml)
Variants: 40mcg/mL, IV Bag
Lot Numbers:
36-260034 (Exp 10/3/2023)
36-260033 (Exp 10/3/2023)
NDC:
72196-6058-1

Quantity: 586 bags

Product: PHENYLephrine added to 0.9% sodium chloride (20mg/250ml)
Variants: 80 mcg/mL, IV Bag
Lot Numbers:
36-260037 (Exp 10/3/2023)
NDC:
72196-7025-1

Quantity: 297 bags

Product: PHENYLephrine added to 0.9% sodium chloride (40mg/250ml)
Variants: 160mcg/mL, IV Bag
Lot Numbers:
36-260036 (Exp 10/3/2023)
NDC:
72196-6092-1

Quantity: 292 bags

Product: PHENYLephrine added to 0.9% sodium chloride (50 mg/250mL)
Variants: 200mcg/mL, IV Bag
Lot Numbers:
36-260038 (Exp 10/3/2023)
NDC:
72196-7039-1

Quantity: 340 bags

Product: EPINEPHrine 2 mg added to dextrose 5% (250mL)
Variants: 8 mcg/mL, IV Bag
Lot Numbers:
36-260049 (Exp 10/3/2023)
NDC:
72196-6030-1

Quantity: 340 bags

Product: oxyTOCIN 30 units added to Lactated Ringer's (500 mL)
Variants: IV Bag
Lot Numbers:
36-260043 (Exp 9/8/2023)
36-260039 (Exp 9/8/2023)
36-262220 (Exp 9/10/2023)
36-262526 (Exp 9/14/2023)
36-262525 (Exp 9/14/2023)
36-262524 (Exp 9/14/2023)
NDC:
72196-6039-1

Quantity: 1,996 bags

Product: oxyTOCIN 30 units added to 0.9% sodium chloride (500 mL)
Variants: IV Bag
Lot Numbers:
36-260031 (Exp 10/3/2023)
36-260027 (Exp 10/3/2023)
36-262533 (Exp 10/9/2023)
36-262532 (Exp 10/9/2023)
36-262531 (Exp 10/9/2023)
36-262530 (Exp 10/9/2023)
36-262529 (Exp 10/9/2023)
36-262528 (Exp 10/9/2023)
36-262527 (Exp 10/9/2023)
NDC:
72196-6044-1

Quantity: 2643 bags

Product: oxyTOCIN 40 units added to 0.9% sodium chloride (1000 mL)
Variants: IV Bag
Lot Numbers:
36-260050 (Exp 10/3/2023)
NDC:
72196-8069-1

Quantity: 298 bags

Product: heparin added to 0.9% sodium chloride (2500 units/500mL)
Variants: 5 units/mL, IV Bag
Lot Numbers:
36-260045 (Exp 9/13/2023)
36-260046 (Exp 9/13/2023)
NDC:
72196-8100-1

Quantity: 577 bags

Product: vancomycin added to 0.9% Sodium Chloride (1.25 g/250 mL)
Variants: 5 mg/mL, 250mL Excel Bag
Lot Numbers:
36-262215 (Exp 10/5/2023)
36-262216 (Exp 10/5/2023)
NDC:
72196-6074-1

Quantity: 477 bags

Product: dilTIAZem 125mg/125mL (1 mg/mL) in 0.9% sodium chloride
Variants: IV Bag
Lot Numbers:
36-262537 (Exp 9/19/2023)
NDC:
72196-6055-1

Quantity: 235 bags

Product: dilTIAZem 125mg/125mL (1 mg/mL) in dextrose 5%
Variants: IV Bag
Lot Numbers:
36-260048 (Exp 9/13/2023)
36-262174 (Exp 9/15/2023)
36-262523 (Exp 9/19/2023)
NDC:
72196-6054-1

Quantity: 703 bags

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92898
Status: Resolved
Manufacturer: Central Admixture Pharmacy Services, Inc.
Sold By: Hospitals; Pharmacies; Healthcare Facilities
Manufactured In: United States
Units Affected: 32 products (304 bags; 184; 84 bags; 84 bags; 100 bags; 786 Bags; 3519 Syringes; 84 bags; 40 bags; 200 bags; 104 bags; 140 bags; 136 bags; 132 bags; 92 bags; 108 bags; 16 bags; 4100 syringes; 586 bags; 297 bags; 292 bags; 340 bags; 340 bags; 292 bags.; 554 bags; 1,996 bags.; 2643 bags; 298 bags; 577 bags; 477 bags; 235 bags; 703 bags.)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.