FDAClass IFebruary 19, 2020

Ketorolac Trom recall: Particulate Matter

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

Why was Ketorolac Trom 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020

Product
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
Recalling firm
RemedyRepack Inc.
Quantity
75 1 ml vials
Distribution
Product distributed in OK and LA.
Recall date
February 19, 2020
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls