Drug product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
D-1013-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2692 bags
- Official record key
drug-enforcement:D-1013-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-241803, 36-241804, Exp. 7/21/2023; 36-243836, Exp. 7/31/2023; 36-246645, Exp. 8/3/2023; 36-246729, Exp. 8/6/2023; 36-248976, Exp. 8/16/2023; 36-249502, Exp. 8/17/2023; 36-252215, 8/31/2023; 36-255872, 36-255875, Exp. 9/10/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility