Baxter Healthcare Corp.: 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015

Is my product affected?

5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015

• Brand DEXTROSE

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corp. is recalling specific lots of 5% Dextrose Injection, USP in VIAFLEX Plastic Containers due to a manufacturing issue that may cause leakage at the administration port. The affected products are 50 mL containers (lot numbers P280115 and P285239, expiring 7/13) and 100 mL containers (lot numbers P280230, P280461, P285288, P285288A, and P285783, expiring 8/13). A total of 730,848 units were distributed nationwide and in Puerto Rico.

The potential leakage at the administration port raises concerns about the sterility of the product. The recall was issued because a sealing problem during manufacturing of the closure assembly could compromise the integrity of the container. The source document does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide & Puerto Rico Quantity: 730,848 units Lot/code info: Lot #: a) Product code 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.2013-11-21
• 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 600152013-05-21
• Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 600152013-05-21
• 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) 2B1308-2013-05-21
• Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-482013-05-21

All FDA (Drug enforcement) recalls