D-926-2013 Class II Terminated
FDA drug recall D-926-2013 was initiated by Hospira, Inc. on Aug 12, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. The recall status is terminated (terminated Oct 28, 2014). Affected quantity: 345,800 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 4, 2013
- Initiation Date
- Aug 12, 2013
- Termination Date
- Oct 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 345,800 vials
Product Description
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Reason for Recall
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Distribution Pattern
Naitonwide
Code Information
Lot 25048DK Exp. 01/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-926-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026