D-624-2013 Class II Terminated
FDA drug recall D-624-2013 was initiated by Baxter Healthcare Corp. on May 21, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 18, 2015). Affected quantity: 845,520 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 10, 2013
- Initiation Date
- May 21, 2013
- Termination Date
- Jun 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 845,520 units
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.
Distribution Pattern
Nationwide & Puerto Rico
Code Information
Lot #: a) Product code 2B0042: P285668, P285668A, P285668C, P285734, Exp 5/13; b) Product code 2B0043: P285395, Exp 5/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-624-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026