Injectable Pain Drug Recalled Over Contamination Concerns

All lots of the American Regent injectable pain drug ketorolac tromethamine, which is used to treat fibromyalgia and other forms of severe persistent pain, have been recalled because they may be contaminated with crystallization and pose a risk of life-threatening injury.

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) approved for use in short-term pain relief of moderate to severe pain. Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. of Shirley, NY.

The drug also is sold in tablet form under the brand name Toradol.

The nationwide voluntary recall involves all lots of American Regent Ketorolac Tromethamine Injection, USP 30 mg/mL in the following forms:

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

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

Other concentrations of American Regent Ketorolac Tromethamine Injection, USP are not being recalled, the FDA and the company said.

Risk of Serious Injuries to Patients

The recall is being initiated because of the potential for serious injuries to patients, including blockage of blood vessels, which can cause pulmonary embolism, pulmonary thrombosis, anaphylactic reactions, and other potentially fatal complications, the Food and Drug Administration said.

The recalled drug was distributed across the United States and to at least one location in Abu Dhabi, United Arab Emirates.

Hospitals, surgical centers, and other healthcare facilities are advised not to use any American Regent Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care. The products should be immediately quarantined for return, the FDA said.

Earlier Recall Expanded

On October 16, 2009, American Regent voluntarily recalled all unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter along with crystallization. The recall did not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.

As a precaution, that earlier recall of only unexpired lots of the drug has been expanded to include all lots, the FDA said.

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