Why it was recalled
Crystallization; identified as calcium salt of Ketorolac
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide, Puerto Rico, Guam, Canada and Singapore
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1242-2015
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 30, 2015
- FDA report date
- Jul 22, 2015
- Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1242-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 71681
- Address
- 600 N Field Dr
- 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
- Postal code
- 60045-4835
- Report date
- Jul 22, 2015
- Product type
- Drugs
- Recall number
- D-1242-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Reason for recall
- Crystallization; identified as calcium salt of Ketorolac
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Recall initiation date
- Jun 30, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 15, 2015