Drug product
oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6032-1
D-1003-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 497 bags
- Official record key
drug-enforcement:D-1003-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-249712, Exp. 8/20/2023; 36-250059, Exp. 8/22/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility