D-0788-2017 Class II Terminated
FDA drug recall D-0788-2017 was initiated by Baxter Healthcare Corporation on May 15, 2017 and is designated Class II. Reason for recall: Lack of assurance of sterility: customer complaints received for the presence of leaks. The recall status is terminated (terminated Aug 10, 2018). Affected quantity: 113,590 bags.
Recall details
- Product Type
- Drugs
- Report Date
- May 24, 2017
- Initiation Date
- May 15, 2017
- Termination Date
- Aug 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113,590 bags
Product description
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48
Reason for recall
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Distribution pattern
US and foreign countries: United Arab Emirates, Colombia, and Canada
Code information
Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0788-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026