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US Drug Company Recalls Defective Product

October 21, 2009

American Regent, a US drug distributor, has recalled Ketorolac Tromethamine Injection USP 30 mg/mL manufactured by Luitpold Pharmaceuticals, Inc. after they were found to be contaminated and could cause blockage of the blood vessels. The products were recalled from drug stores, clinics, surgical centers and other health facilities last October 16.

A NSAID pain reliever, it can also cause induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. It can result to foreign body granulomas and local irritation at the injection site. It is used for moderate to severe pain. The vials are NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial and NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL).

The product was distributed in the US and Abu Dhabi.

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