Baxter Healthcare Corp.: 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

Is my product affected?

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 60015

• Brand HEPARIN SODIUM IN SODIUM CHLORIDE

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

What happened

Baxter Healthcare Corp. recalled specific lots of Heparin Sodium and 0.9% Sodium Chloride Injection products distributed nationwide and in Puerto Rico due to a manufacturing defect. The affected products are: Product code 2B0944 (2000 USP Units, 1000mL, Lot #N001164, Exp 7/13) and Product code 2B0953 (Lot #N001396, Exp 11/13). A sealing problem at the administration port during manufacturing could potentially allow leakage from these specific lot numbers, which raises concerns about the sterility assurance of the products.

Because these are sterile injectable medications, any potential leakage could compromise their safety for patient use. If you have one of these specific lot numbers, you should not use the product. The recall source does not specify what remedy consumers should pursue.

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: N/A Lot/code info: Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

• 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
• 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 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
• Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC 2013-06-04

All FDA (Drug enforcement) recalls