Drug product
oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
D-0975-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 751 bags
- Official record key
drug-enforcement:D-0975-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-247802, 36-247803, Exp. 7/15/2023; 36-254395, Exp. 8/10/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility