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American Regent Recalls All Lots of Ketorolac


American Regent has issued a nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial

NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

The recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product.

This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

OCT-21-09: American Regent Recalls All Lots of Ketorolac Tromethamine Injection [FDA: RECALLS]

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Published on Oct-21-09

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READER COMMENTS

Posted by
Elliott Reiss
on
I was giving a shot toradol for a back injury that I suffered at work and ever since then (4 months) I have been having extreme pain, tightness, numbeness, and tingling n my legs, feet, arms, and hands!

I would like t know if my batch was recalled.

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