Why it was recalled
Crystallization
Product description
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
Lot numbers, UPCs & expiration codes
NDC 61786-0055-01, Lot # B00484449-100914, Lot # B0062349-121914, Lot # B006655-011415; Expiration Date: 04/01/2016
Where it was sold
PA, OK.
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-0484-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 18, 2015
- FDA report date
- Apr 15, 2015
- Quantity
- 25 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0484-2015, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 70549
- Address
- 625 Kolter Dr
- Address (line 2)
- Suite 4
- Code information
- NDC 61786-0055-01, Lot # B00484449-100914, Lot # B0062349-121914, Lot # B006655-011415; Expiration Date: 04/01/2016
- Postal code
- 15701-3570
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-0484-2015
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 25 vials
- Termination date
- Aug 18, 2015
- Reason for recall
- Crystallization
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
- Distribution pattern
- PA, OK.
- Recall initiation date
- Feb 18, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 9, 2015