D-1514-2019 Class II Terminated
FDA drug recall D-1514-2019 was initiated by Baxter Healthcare Corporation on Jul 18, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Bags have potential to leak. The recall status is terminated (terminated Apr 19, 2021). Affected quantity: 139,680 Containers.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 31, 2019
- Initiation Date
- Jul 18, 2019
- Termination Date
- Apr 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139,680 Containers
Product description
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Reason for recall
Lack of Assurance of Sterility: Bags have potential to leak.
Distribution pattern
Nationwide in the United States and Puerto Rico.
Code information
Lot #s: P389684; P389742, Exp. 8/31/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1514-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026