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Drug recall · FDA · Published December 27, 2019

RemedyRepack Inc. recalls Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA

RemedyRePack recalls Ketorolac Trom injections due to small black particles found during visual inspection. Affected products have specific NDC and lot numbers. Stop using immediately.

🇺🇸 FDA recall #D-0867-2020DrugRemedyRePack ›
Take action

Contact the company & request your remedy

Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

RemedyRePack is recalling Ketorolac Trom injections that were repackaged at their facility. Small black particles were found during routine checks, which could cause serious injury if injected. Read more at govinfonow.com/recall/37490-remedyrepack-ketorolac-trom-recall-particulate-matter-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37490-remedyrepack-ketorolac-trom-recall-particulate-matter-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0867-2020

Cite this page

“RemedyRePack Ketorolac Trom Recall: Particulate Matter Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37490-remedyrepack-ketorolac-trom-recall-particulate-matter-risk. Based on FDA recall #D-0867-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0867-2020%22&limit=1).

Why it’s dangerous

Small black particles in the medication could cause serious injury or death if injected. The particles were noticed during routine visual inspections of the repackaged product.

Who’s affected

People with prescriptions for Ketorolac Trom injections from RemedyRePack. Those using the medication for pain or inflammation are most at risk.

How to tell if you have this one

Check for NDC 70518-1239-00 with lot numbers B0444562-060118 (exp 04/2020) or B0537002-112118 (exp 07/2020). The product is a 1mL injection for IV or IM use only.

  • Brand
    RemedyRePack
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discard the product if you have it. Do not use the medication.

✎ GovInfoNow

Questions people ask

Why was this product recalled?

The manufacturer found small black particles during routine visual inspections of the repackaged medication.

What is the specific product number?

NDC 70518-1239-00 with lot numbers B0444562-060118 (exp 04/2020) or B0537002-112118 (exp 07/2020).

Is there a fix or replacement available?

The recall does not mention any replacement or fix; the product must be discarded.

Take action

Contact RemedyRePack

We’ve drafted a message you can send RemedyRePack to request your refund or repair — edit it as you like.

Subject: Recall D-0867-2020 — RemedyRePack RemedyRePack

Hello,

I own a RemedyRePack that is covered by recall D-0867-2020 from RemedyRePack.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0867-2020 (December 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0867-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA