D-619-2013 Class II Terminated
FDA drug recall D-619-2013 was initiated by Hospira Inc. on May 4, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. The recall status is terminated (terminated Jul 17, 2015). Affected quantity: 2,933,936 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 3, 2013
- Initiation Date
- May 4, 2012
- Termination Date
- Jul 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,933,936 units
Product Description
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Reason for Recall
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Distribution Pattern
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Code Information
Lot #: a) 11-085-JT, Exp 11/13; b) 06-111-JT, Exp 12/12, c) 93-030-JT, 14-044-JT, Exp 9/12
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-619-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026