FDA recall D-0864-2020

Product

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

Reason for recall

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-12-17

Report date

2020-01-22

Termination date

2021-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cherry Hill, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0864-2020