Why it was recalled
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Product description
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Lot numbers, UPCs & expiration codes
Lot 25048DK Exp. 01/15
Where it was sold
Naitonwide
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-926-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2013
- FDA report date
- Sep 4, 2013
- Quantity
- 345,800 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-926-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66050
- Address
- 600 N Field Dr Bldg J45
- Code information
- Lot 25048DK Exp. 01/15
- Postal code
- 60045
- Report date
- Sep 4, 2013
- Product type
- Drugs
- Recall number
- D-926-2013
- Classification
- Class II
- Recalling firm
- Hospira, Inc.
- Product quantity
- 345,800 vials
- Termination date
- Oct 28, 2014
- Reason for recall
- Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
- Distribution pattern
- Naitonwide
- Recall initiation date
- Aug 12, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2013