Drug product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
D-0973-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3821 bags
- Official record key
drug-enforcement:D-0973-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-241662, Exp. 7/20/2023; 36-242725, Exp. 7/26/2023; 36-243607, Exp. 7/30/2023; 36-243837, 36-243838, Exp. 7/31/2023; 36-245517, 36-245523, 36-245525, 36-245662, Exp. 8/2/2023; 36-247254, 36-247255, Exp. 8/8/2023; 36-247983, Exp. 8/10/2023; 36-254917, Exp. 9/5/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility