FDA Drug recall D-1128-2018
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
- FDA Drug
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18 by Baxter Healthcare, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1128-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-21 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | MS, TX |
Product
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Reason
CGMP Deviations
Identifiers
| ndc | 0338-0049-01 |
|---|---|
| ndc | 0338-0049-02 |
| ndc | 0338-0049-03 |
| ndc | 0338-0049-04 |
| ndc | 0338-0049-10 |
| ndc | 0338-0049-41 |
| ndc | 0338-0049-11 |
| ndc | 0338-0049-31 |
| ndc | 0338-0049-48 |
| ndc | 0338-0049-18 |
| ndc | 0338-0049-38 |
| ndc | 0338-0043-03 |
| ndc | 0338-0043-04 |
| code_info | Lot #: P380287, Exp. date 12/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1128-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.