Drug product
oxyTOCIN 30 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: 72196-6039-1
D-1132-2023
Product summary
- Event
- Event 92898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,996 bags.
- Official record key
drug-enforcement:D-1132-2023
Official wording
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Code information: Lot# 36-260043, 36-260039, Exp 9/8/2023; 36-262220, Exp 9/10/2023; 36-262526, 36-262525, 36-262524, Exp 9/14/2023. ;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility