Status
Terminated
Drug Enforcement D-0978-2023
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 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
- Product quantity
- 11,824 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-0978-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- Lot: 36-243555, 36-243556, Exp. 7/10/2023; 36-245117, 36-245118, 36-245119, 36-245120, Exp. 7/12/2023; 36-246163, 36-246164, Exp. 7/14/2023; 36-247010, Exp. 7/18/2023; 36-248226, 36-248229, 36-248232, 36-248248, Exp. 7/24/2023; 36-249829, 36-249830, 36-249831, 36-249832, Exp. 8/1/2023; 36-250047, 36-250048, 36-250049, 36-250050, Exp. 8/2/2023; 36-250289, 36-250290, 36-250291, 36-250293, Exp. 8/3/2023; 36-251057, 36-251058, 36-251060, Exp. 8/4/2023; 36-251385, 36-251386, 36-251387, 36-251388, Exp. 8/7/2023; 36-251448, 36-251449, 36-251450, Exp. 8/8/2023; 36-252462, Exp. 8/14/2023; 36-254679, 36-254681, Exp. 8/16/2023; 36-255116, 36-255117, 36-255118, Exp. 8/17/2023; 36-255488, Exp. 8/18/2023.
- More code info
- —