Fresenius Kabi USA is recalling approximately 945,425 vials of Ketorolac Tromethamine Injection, USP (30 mg per mL), a prescription nonsteroidal anti-inflammatory drug (NSAID). The recall was initiated because particulate matter (foreign particles) was discovered in reserve sample vials held by the company. If these particles are injected, they can cause serious health complications, though no patient injuries have been reported to date. Consumers and healthcare providers should check their stock for 1 mL single-dose vials belonging to lot number 6121083.
The presence of particulate matter in an injectable medication can cause local irritation, inflammation, or more severe issues such as the blockage of blood vessels (embolism). These blockages can travel to the lungs or other organs, potentially leading to life-threatening complications or systemic allergic reactions.
Drug recall remedy
Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 ml single use vial
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 · FDA Press Release · Raw API Response
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