Why it was recalled
Presence of Particulate Matter - found in reserve sample vials at the firm.
Product description
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Lot numbers, UPCs & expiration codes
Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021
Where it was sold
USA Nationwide 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-1297-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 20, 2020
- FDA report date
- Jun 17, 2020
- Quantity
- 3,497,575 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1297-2020, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 85504
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021
- Postal code
- 60047-8930
- Report date
- Jun 17, 2020
- Product type
- Drugs
- Recall number
- D-1297-2020
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 3,497,575 vials
- Termination date
- Oct 16, 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, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
- Distribution pattern
- USA Nationwide and Puerto Rico
- Recall initiation date
- Apr 20, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 8, 2020