Drug product
oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1
D-0972-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1937 bags
- Official record key
drug-enforcement:D-0972-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-246733, Exp. 7/12/2023; 36-247777, 36-247779, Exp. 7/15/2023; 36-250334, Exp. 7/29/2023; 36-251383, 36-251384, Exp. 8/2/2023; 36-251990, Exp. 8/5/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility