D-616-2013 Class II Terminated
FDA drug recall D-616-2013 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: 216,396 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
- 216,396 units
Product Description
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), 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) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-JT, Exp 7/12
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-616-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026