Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack...
FDA Recall #D-0867-2020 — Class I — December 27, 2019
Product Description
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
Reason for Recall
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.
Recalling Firm
RemedyRepack Inc. — Indiana, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
75 1 ml vials
Distribution
Product distributed in OK and LA.
Code Information
Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated