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
Reported: July 10, 2013 Initiated: May 21, 2013 #D-624-2013
Product Description
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
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.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 845,520 units
- Distribution
- Nationwide & Puerto Rico
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Baxter Healthcare Corp.. Units affected: 845,520 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2013. Severity: Moderate. Recall number: D-624-2013.
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