D-1111-2023 Class II Terminated
FDA drug recall D-1111-2023 was initiated by Central Admixture Pharmacy Services, Inc. on August 17, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles The recall status is terminated (terminated March 27, 2025). Affected quantity: 100 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- September 6, 2023
- Initiation Date
- August 17, 2023
- Termination Date
- March 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 bags
Product Description
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 36-262881, Exp 8/27/2023.