D-1017-2023 Class II Terminated
FDA drug recall D-1017-2023 was initiated by Central Admixture Pharmacy Services, Inc. on July 14, 2023 and is designated Class II. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. The recall status is terminated (terminated March 28, 2025). Affected quantity: 48.
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 14, 2023
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48
Product Description
CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 36-251643, Exp. 7/13/2023