RemedyRepack Inc. recalls Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 157…

Recall date

December 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0867-2020

FDA classification

Class I

Brand / firm

RemedyRepack Inc.

Sold / distributed

Product distributed in OK and LA.

Why it was recalled

Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00