Drug product
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
D-0979-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,834 bags
- Official record key
drug-enforcement:D-0979-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: 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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility