D-0483-2015 Class II Terminated
FDA drug recall D-0483-2015 was initiated by Hospira Inc. on Jan 23, 2015 and is designated Class II. Reason for recall: Crystallization The recall status is terminated (terminated Feb 4, 2016). Affected quantity: HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 15, 2015
- Initiation Date
- Jan 23, 2015
- Termination Date
- Feb 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials
Product Description
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
Reason for Recall
Crystallization
Distribution Pattern
U.S. Nationwide and International: Guam and Singapore.
Code Information
NDC 0409-3796-01, Lot number: 26-098-DK, Exp. Date:1FEB2015; Lot number: 29-239-DK, 29-240-DK, Exp. Date:1MAY2015; Lot number: 34-540-DK, Exp. Date:1OCT2015; Lot number: 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, Exp. Date:1JAN2016; Lot number: 41-282-DK, 41-284-DK, Exp. Date:1MAY2016; Lot number: 44-076-DK, Exp. Date:1AUG2016; Lot number: 45-240-DK, Exp. Date:1SEP2016 and Lot number: 46-306-DK, Exp. Date:1OCT2016 AND NOVAPLUS label NDC 0409-3796-49, Lot number: 26-097-DK, Exp. Date:1FEB2015.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0483-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026