CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
Reported: August 9, 2023 Initiated: July 14, 2023 #D-1041-2023
Product Description
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Details
- Recalling Firm
- Central Admixture Pharmacy Services, Inc.
- Units Affected
- 104 bags
- Distribution
- Nationwide in the USA
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 104 bags.
Why was this product recalled? ▼
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 9, 2023. Severity: Moderate. Recall number: D-1041-2023.
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