D-0973-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 14, 2023
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3821 bags
Product Description
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 36-241662, Exp. 7/20/2023; 36-242725, Exp. 7/26/2023; 36-243607, Exp. 7/30/2023; 36-243837, 36-243838, Exp. 7/31/2023; 36-245517, 36-245523, 36-245525, 36-245662, Exp. 8/2/2023; 36-247254, 36-247255, Exp. 8/8/2023; 36-247983, Exp. 8/10/2023; 36-254917, Exp. 9/5/2023