Food, drugs, devices › RemedyRepack Inc.
Drug recall: Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 1570
RemedyRepack Inc. (Indiana, PA) initiated this drug recall on 27 Dec 2019; FDA lists 1 product record under event 84900, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 10% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 18 Aug 2020. Initiation: voluntary: firm initiated. RemedyRepack Inc. has 36 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
RemedyRepack Inc., Indiana, PA.
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."
Distribution
"Product distributed in OK and LA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 75 1 ml vials | Class I | Terminated | 19 Feb 2020 |
Context
Other enforcement events for RemedyRepack Inc.
All 36 events for RemedyRepack Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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 does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Product distributed in OK and LA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.