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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 Glass Particulate Matter

Agency Publication Date: October 21, 2025
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Summary

Aspiro Pharma Limited has recalled certain lots of Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), a prescription medication used for pain management. The recall was initiated because the vials may contain particulate matter identified as glass. Using an injectable medication contaminated with glass particles can lead to serious health complications, including local irritation, inflammation, or more severe systemic issues if the particles travel through the bloodstream.

Risk

The presence of glass particles in an injectable drug poses a risk of vascular irritation, inflammation, or the formation of granulomas. In severe cases, these particles could cause blockages in vital organs or systemic adverse reactions.

What You Should Do

  1. Stop using the recalled product immediately. Contact your healthcare provider or distributor to arrange for the return of any remaining stock.
  2. Check your vials and cartons for the following lot numbers and expiration dates: AS1240347A (Exp 09/2026), AS1240144A (Exp 05/2026), AS1240145A (Exp 06/2026), AS1240146A (Exp 06/2026), and AS1250295A (Exp 05/2027).
  3. Verify the NDC numbers on your packaging: NDC 31722-307-25 (Carton) or NDC 31722-307-02 (Vial label).
  4. If you have experienced any adverse health effects after receiving this injection, contact your healthcare provider immediately.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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 Camber Pharmaceuticals, Inc.
Variants: 60 mg/2 mL, 30 mg/mL, 2 mL Single-Dose Vial, Intramuscular Use Only
Lot Numbers:
AS1240347A (Exp 09/2026)
AS1240144A (Exp 05/2026)
AS1240145A (Exp 06/2026)
AS1240146A (Exp 06/2026)
AS1250295A (Exp 05/2027)
NDC:
31722-307-25
31722-307-02

Manufactured for Camber Pharmaceuticals, Inc. by Aspiro Pharma Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97711
Status: Active
Manufacturer: Aspiro Pharma Limited
Sold By: Hospitals; Wholesalers; Distributors
Manufactured In: India
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.