Status
Terminated
Drug Enforcement D-0979-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 28, 2025
Product Information
- Product description
- heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
- Product quantity
- 5,834 bags
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Address
-
2200 S 43rd Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0979-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- Lot: 36-246161, Exp. 7/14/2023; 36-247002, 36-247006, 36-247007, Exp. 7/18/2023; 36-247673, 36-247674, Exp. 7/20/2023; 36-247832, 36-247833, 36-247835, 36-247836, Exp. 7/21/2023; 36-248991, Exp. 7/27/2023; 36-249593, Exp. 7/29/2023; 36-250046, Exp. 8/2/2023; 36-251444, 36-251445, 36-251446, 36-251447, Exp. 8/8/2023; 36-251968, Exp. 8/10/2023; 36-254379, 36-254380, Exp. 8/15/2023; 36-254684, Exp. 8/16/2023.
- More code info
- —