D-1816-2015 Class II Terminated
FDA drug recall D-1816-2015 was initiated by Baxter Healthcare Corporation on Sep 2, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch. The recall status is terminated (terminated Sep 15, 2016). Affected quantity: 139,104 Bags.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 30, 2015
- Initiation Date
- Sep 2, 2015
- Termination Date
- Sep 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139,104 Bags
Product description
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
Reason for recall
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot #: P329821, Exp 08/31/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1816-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026