RemedyRepack Recalls Ketorolac Injection Due to Crystallization
RemedyRepack Inc. recalls specific lots of Ketorolac Tromethamine injection due to crystallization. Check lot numbers and expiration dates immediately.
Use caution until it’s fixed
Crystallization
Contact the company
What happened, in plain English
RemedyRepack Inc. is recalling Ketorolac Tromethamine Injection, a 30 mg/mL solution in 1 mL glass vials, because the drug has crystallized. The affected products were repackaged by RemedyRepack in Indiana, PA, and manufactured by Hospira, Inc. This recall affects only 25 units distributed to Pennsylvania and Oklahoma. Read more at govinfonow.com/recall/44737-remedyrepack-inc-recalls-ketorolac-trom-30-mg-ml-inj-1.
Source Summary by GovInfoNow · govinfonow.com/recall/44737-remedyrepack-inc-recalls-ketorolac-trom-30-mg-ml-inj-1 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0974-2015
Cite this page
“RemedyRepack Recalls Ketorolac Injection Due to Crystallization.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44737-remedyrepack-inc-recalls-ketorolac-trom-30-mg-ml-inj-1. Based on FDA recall #D-0974-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0974-2015%22&limit=1).
Why it’s dangerous
The crystallization of the drug can alter its chemical composition and potency, potentially making it ineffective or unsafe for injection. Using a crystallized injectable medication poses a risk of improper dosing or adverse reactions.
Who’s affected
Patients or healthcare providers in Pennsylvania and Oklahoma who received Ketorolac Tromethamine Injection from the specific lots listed below are affected. The risk is primarily to those using these specific vials for medical treatment.
How to tell if you have this one
Look for Ketorolac Tromethamine Injection, 30 mg/mL, in 1 mL glass vials repackaged individually inside an amber glass bottle. Check for NDC 61786-0055-01 and the following lot numbers: B0069266-013015, B0069264-013015, and B0066712-011415. The expiration date for these lots is 9/01/2016.
- Brand
RemedyRepack- Category
Drug
What to do — step by step
Check Lot Numbers
Verify if your vials match the recalled lot numbers B0069266-013015, B0069264-013015, or B0066712-011415.
Contact Provider
If you have the recalled product, contact your healthcare provider or pharmacist for instructions on disposal or replacement.
Where it went and when
Where it was distributed
Distributed in Oklahoma and Pennsylvania.
FDA distribution: “PA and OK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Oklahoma, Pennsylvania.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0974-2015 (April 23, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0974-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.