FDA Drug recall D-628-2013
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11)
- FDA Drug
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11) by Baxter Healthcare, citing lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-628-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-21 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015
Reason
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
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 #: a) Product code 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346…Lot #: a) Product code 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346, P285791, Exp 8/13; c) Product code 2B1306: P285601, Exp 5/13; d) Product code 2B1307: P280347, Exp 8/13; e) Product code 2B1308: P280404, P280404A, P285635, P285858, Exp 11/13; e) Product code 2B1309: P280149, Exp 8/13 |
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-628-2013%22
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