D-0827-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- November 13, 2017
- Termination Date
- December 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,356 1 liter bags
Product Description
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot # 17LU05005; Exp. 09/18 Part Number 060-10109