FDA recall D-0184-2021

Fresenius Kabi USA, LLC · Class II · drug

Product

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

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: 2020-12-17
Report date: 2021-01-06
Termination date: 2023-06-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0184-2021