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 June 17, 2020).
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- April 20, 2020
- Posted
- June 17, 2020
- Recall Number
- D-1296-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,314,400 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
USA Nationwide and Puerto Rico
Lot / Code Info
Lot #: 6118737, 6118902, Exp 04/2020; 6119052, Exp 05/2020; 6119752, Exp 08/2020; 6122349, Exp 07/2021; 6122538, Exp 09/2021
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