Why it was recalled
Crystallization
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
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.
Where it was sold
U.S. Nationwide and International: Guam 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-0483-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 23, 2015
- FDA report date
- Apr 15, 2015
- Quantity
- HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0483-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70515
- Address
- 275 N Field Dr
- 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.
- Postal code
- 60045-2579
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-0483-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials
- Termination date
- Feb 4, 2016
- Reason for recall
- Crystallization
- 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
- U.S. Nationwide and International: Guam and Singapore.
- Recall initiation date
- Jan 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2015