FDA Drug recall D-481-2015
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Produ…
- FDA Drug
- Class I
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class I recall of 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Produ… by Baxter Healthcare, citing presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-481-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-12-04 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Reason
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Identifiers
| ndc | 0338-0553-11 |
|---|---|
| ndc | 0338-0553-18 |
| code_info | Lot #: P317891, P317842, Exp 05/15 |
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-481-2015%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.