D-1240-2015 Class II Terminated
FDA drug recall D-1240-2015 was initiated by Hospira Inc. on Jul 2, 2015 and is designated Class II. Reason for recall: Lack of assurance of sterility: Potential channel leaks near the threaded vial port. The recall status is terminated (terminated Nov 17, 2016). Affected quantity: 314600 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 22, 2015
- Initiation Date
- Jul 2, 2015
- Termination Date
- Nov 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 314600 bags
Product Description
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Reason for Recall
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Distribution Pattern
United States
Code Information
Lot #: 49-084-JT; 49-119-JT
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1240-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026