FDA Drug recall D-1816-2015
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deer…
- FDA Drug
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deer… by Baxter Healthcare, citing lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1816-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-02 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
Reason
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
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 #: P329821, Exp 08/31/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1816-2015%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.