D-0284-2015 Class II Terminated
FDA drug recall D-0284-2015 was initiated by Hospira Inc. on Oct 14, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. The recall status is terminated (terminated Dec 28, 2015). Affected quantity: 305,664 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 3, 2014
- Initiation Date
- Oct 14, 2014
- Termination Date
- Dec 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305,664 bags
Product Description
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Distribution Pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Code Information
Lot # 32-081-JT; Exp. 08/15 Lot # 34-115-JT; Exp. 10/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0284-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026