RecallRadar

FDA Drug recall D-0484-2015

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA,…

On 2015-04-15 the FDA classified a Class II recall of KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA,… by Remedyrepack, citing crystallization.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0484-2015
ClassificationClass II
Statusterminated
Initiated2015-02-18
Published2015-04-15
Last updated2026-09-13 11:51 UTC
CompanyRemedyrepack
DistributionOK, PA

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

Crystallization

Identifiers

code_infoNDC 61786-0055-01, Lot # B00484449-100914, Lot # B0062349-121914, Lot # B006655-011415; Expiration Date: 04/01/2016

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0484-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.