D-1128-2018 Class II Terminated
FDA drug recall D-1128-2018 was initiated by Baxter Healthcare Corporation on Aug 21, 2018 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Oct 30, 2019). Affected quantity: 33600 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2018
- Initiation Date
- Aug 21, 2018
- Termination Date
- Oct 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33600 bags
Product Description
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Reason for Recall
CGMP Deviations
Distribution Pattern
TX and MS only
Code Information
Lot #: P380287, Exp. date 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-1128-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026