D-1241-2015 Class II Ongoing
FDA drug recall D-1241-2015 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: 12,460,975 vials(Hospira label); 3,016,500 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
- 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
Product Description
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
Reason for Recall
Crystallization; identified as calcium salt of Ketorolac
Distribution Pattern
Nationwide, Puerto Rico, Guam, Canada and Singapore
Code Information
31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1241-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026