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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ketorolac Tromethamine Injection Recalled for Cross-Contamination Risk

Agency Publication Date: August 17, 2022
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Summary

Nephron Pharmaceutical Corporation is recalling 5,040 vials of Ketorolac Tromethamine Injection (60 mg/2 mL). The recall is due to manufacturing deviations that may have led to potential cross-contamination of the medication. No incidents or injuries have been reported to date regarding this issue.

Risk

Cross-contamination in an injectable medication can introduce unintended substances into the drug, which may cause adverse reactions or reduce the effectiveness of the treatment.

What You Should Do

  1. This recall affects Nephron Pharmaceutical Corporation Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single-dose vials with NDC 0487-6232-01 and lot number 023011 (Exp 8/31/2022).
  2. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL)by Nephron Pharmaceutical Corporation
Variants: 60 mg/2 mL (30 mg/mL), 2 mL single dose vial
Lot Numbers:
023011 (Exp 8/31/2022)
NDC:
0487-6232-01

Recall Number: D-1354-2022; Distributed Nationwide in the USA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90703
Status: Resolved
Manufacturer: Nephron Sc Inc
Sold By: Hospitals; Surgical Centers; Wholesalers
Manufactured In: United States
Units Affected: 5040 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.