D-316-2013 Class II Terminated
FDA drug recall D-316-2013 was initiated by Hospira Inc. on Feb 26, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. The recall status is terminated (terminated Nov 10, 2014). Affected quantity: 266,900 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2013
- Initiation Date
- Feb 26, 2013
- Termination Date
- Nov 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 266,900 vials
Product Description
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 23-320-DK and 23-321-DK Exp. 11/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-316-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026