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

FDA recall notice · announced February 19, 2020 · Remedyrepack

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

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.

Notes

Distribution: Product distributed in OK and LA.
Lot/code information: Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020
Quantity: 75 1 ml vials
Status: Terminated
Products in this recall event:
- 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 (D-0867-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.