D-0948-2023 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
- 3,980 bags
Product Description
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 36-245576, Exp. 8/2/2023; 36-254436, 36-254442, Exp. 9/5/2023; 36-255131, Exp. 9/6/2023; 36-256045, Exp. 9/11/2023; 36-239523, Exp. 7/12/2023; 36-248987, Exp. 8/16/2023; 36-240797, Exp. 7/17/2023; 36-241979, Exp. 7/24/2023; 36-242705, Exp. 7/26/2023; 36-251733, 36-251738, Exp. 8/29/2023.