Baxter Healthcare Corp.: 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 60015

Is my product affected?

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 60015

• Brand SODIUM CHLORIDE

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

What happened

Baxter Healthcare Corp. is recalling specific lots of 0.9% Sodium Chloride Injection, USP in MINI-BAG Plus containers (50 mL and 100 mL sizes) distributed nationwide and in Puerto Rico. The recall affects 845,520 units due to a manufacturing defect in the sealing of the closure assembly at the administration port that could cause leakage. The affected lots are: for the 50 mL product (NDC 0338-0553-11), lot numbers P285668, P285668A, P285668C, and P285734 with expiration date 5/13; and for the 100 mL product (NDC 0338-0553-18), lot number P285395 with expiration date 5/13.

The potential for leakage means there is no assurance of sterility for these products. The source document does not specify what actions affected consumers should take in response to 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: 845,520 units Lot/code info: Lot #: a) Product code 2B0042: P285668, P285668A, P285668C, P285734, Exp 5/13; b) Product code 2B0043: P285395, Exp 5/13

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

• 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
• 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcar2013-11-21
• SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 9186102018-11-15
• SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 9186202018-11-15
• 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-102022-10-11

All FDA (Drug enforcement) recalls