D-0777-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2023
- Initiation Date
- May 23, 2023
- Termination Date
- May 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,424 bags
Product Description
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Reason for Recall
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Distribution Pattern
Product was distributed to 32 clinics in SC, NC and VA.
Code Information
Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024