D-1135-2023 Class II Terminated
FDA drug recall D-1135-2023 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: 577 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
- 577 bags
Product Description
heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 36-260045, 36-260046, Exp 9/13/2023. ;