Drug product
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
D-1133-2023
Product summary
- Event
- Event 92898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2643 bags
- Official record key
drug-enforcement:D-1133-2023
Official wording
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Code information: Lot# 36-260031, 36-260027, Exp 10/3/2023; 36-262533,36-262532, 36-262531, 36-262530, 36-262529, 36-262528, 36-262527, Exp 10/9/2023. ;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility