Drug product
heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8000-1
D-0974-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 358 bags
- Official record key
drug-enforcement:D-0974-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-249694, 36-249695, Exp. 7/31/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility