Hikma Pharmaceuticals USA Inc. is recalling 127,527 units of Ketorolac Tromethamine Injection, USP (30 mg/mL and 60 mg/2 mL) due to the presence of particulate matter identified as polydimethylsiloxane (PDMS). This medication, often used for pain management, was distributed nationwide in 1 mL and 2 mL single-dose vials. The defect involves visible particles found within the solution, which could lead to severe health complications if injected.
Injecting a product containing particulate matter can cause local inflammation, granulomas, or serious systemic issues such as blood clots or embolisms, which can travel to the lungs, heart, or brain and may be life-threatening.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
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.
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 · Raw API Response
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