D-1242-2015 Class II Ongoing
FDA drug recall D-1242-2015 was initiated by Hospira Inc. on Jun 30, 2015 and is designated Class II. Reason for recall: Crystallization; identified as calcium salt of Ketorolac The recall status is ongoing. Affected quantity: 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label).
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 22, 2015
- Initiation Date
- Jun 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
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; identified as calcium salt of Ketorolac
Distribution Pattern
Nationwide, Puerto Rico, Guam, Canada and Singapore
Code Information
31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1242-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026