FDA recall D-1297-2020

Product

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.

Reason for recall

Presence of Particulate Matter - found in reserve sample vials at the firm.

Distribution

USA Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-04-20

Report date

2020-06-17

Termination date

2023-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1297-2020