FDA recall D-1354-2022

Product

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01

Reason for recall

cGMP Deviations: deviations leading to potential cross-contamination.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-08-10

Report date

2022-08-24

Termination date

2024-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1354-2022