FDA Drug recall D-0867-2020
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 Drug
- Class I
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class I recall of 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 by Remedyrepack, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0867-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-12-27 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | LA, OK |
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
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.
Identifiers
| code_info | Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0867-2020%22
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