FDA recall D-0484-2015

RemedyRepack Inc. · Class II · drug

Product

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01

Reason for recall

Crystallization

Distribution

PA, OK.

Key facts

Status
Terminated
Initiation date
2015-02-18
Report date
2015-04-15
Termination date
2015-08-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0484-2015