Why it was recalled
Presence of Particulate Matter - found in reserve sample vials at the firm.
Product description
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Lot numbers, UPCs & expiration codes
Lot # 6121083, Exp 2/2021
Where it was sold
Nationwide USA and Puerto Rico
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-0245-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 23, 2020
- FDA report date
- Feb 3, 2021
- Quantity
- 945,425 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0245-2021, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87082
- Address
- 3 Corporate Dr
- Code information
- Lot # 6121083, Exp 2/2021
- Postal code
- 60047-8930
- Report date
- Feb 3, 2021
- Product type
- Drugs
- Recall number
- D-0245-2021
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 945,425 vials
- Termination date
- Jun 9, 2023
- Reason for recall
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Dec 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 27, 2021