Home > FDA MedWatch > FDA MedWatch – Acetadote (acetylcysteine) Injection: Recall

FDA MedWatch – Acetadote (acetylcysteine) Injection: Recall

ISSUE: Cumberland Pharmaceuticals Inc. recalled 6 lots of Acetadote (acetylcysteine) Injection, 20% solution (200mg/mL) in 30 mL single dose glass vials as a precautionary measure based on observed particulate matter found in a very small number of vials. The source of the particulate matter was from the glass vial produced by a former supplier.

BACKGROUND: Used in the emergency department, Acetadote is administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. This product was distributed to U.S. wholesalers and distributors nationwide, please refer to the firm press release for lot numbers being recalled.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

CLICK HERE to read the complete MedWatch 2011 Safety summary.

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