Class I
Terminated
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.
This recall has been terminated (originally issued February 3, 2021).
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- December 23, 2020
- Posted
- February 3, 2021
- Recall Number
- D-0245-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 945,425 vials
- Firm Location
- Lake Zurich, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lot # 6121083, Exp 2/2021
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