FDA recall D-1335-2020

Product

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350

Reason for recall

Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac

Distribution

Distributed Nationwide in the US.

Key facts

Status

Terminated

Initiation date

2020-04-23

Report date

2020-07-01

Termination date

2021-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1335-2020