Herbal Spotlight
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 ketorolac tromethamine injection |
| Generic ketorolac tromethamine |
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Pharmaceutical
company:
American Regent
www.americanregent.com |
NEW WARNING
The Food and Drug Administration (FDA) and American Regent, the manufacturers of the generic ketorolac tromethamine, USP 30 mg/ml, notified health care professionals about a voluntary recall of lots of the drug. The involved lots, which were distributed nationwide, are:
- NDC# 0517-0801-25 (30 mg/ml, 1-ml single-dose vials)
- NDC# 0517-0902-25 (30 mg/ml, 2-ml single-dose vials).
These vials may contain particulate matter, which may obstruct blood vessels and cause pulmonary emboli or thrombosis. Particulate matter may also activate platelets, neutrophils, or both and induce anaphylactic reactions. Other adverse effects that may result from particulate matter include foreign body granulomas and injection site irritation.
Hospitals, surgical centers, clinics, and other health care facilities should stop using ketorolac tromethamine injection 30 mg/ml immediately and return it to the manufacturer. American Regent will credit accounts for all returned ketorolac tromethamine injection, USP products. Those with questions about the return process may call American Regent's Customer Service Department at 1-800-645-1706, Monday through Friday from 8:30 a.m. to 7:00 p.m. Eastern time. Hospitals, surgical centers, clinics, health care providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.
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