D-1190-2018 Class II Terminated
FDA drug recall D-1190-2018 was initiated by Baxter Healthcare Corporation on Sep 6, 2018 and is designated Class II. Reason for recall: cGMP Deviation The recall status is terminated (terminated Oct 1, 2020). Affected quantity: 5184 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 26, 2018
- Initiation Date
- Sep 6, 2018
- Termination Date
- Oct 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5184 bags
Product Description
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Reason for Recall
cGMP Deviation
Distribution Pattern
Nationwide.
Code Information
Lot: P380063 Exp. 12/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1190-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026