Acetylcysteine Injection (Acetadote)
January 3, 2011
Cumberland Pharmaceuticals has voluntarily recalled 6 lots of acetylcysteine 200 mg/mL (20%) injection (Acetadote) in 30 mL single dose vials (NDC 66220-0107-30) as a precaution. Particulate matter was found in a small number of vials and may pose a safety risk if administered to patients. The source of the particulates is believed to be glass vials made by a former supplier; the company has since switched to a new vial supplier. No adverse reactions have been reported as a result of the particulates.
Only NDC 66220-0107-30 is affected. The affected products were shipped to wholesalers throughout 2009. The recall affects the following lot numbers:
- Lot # 090304 (expiration Feb 2011)
- Lot # 090331 (expiration Feb 2011)
- Lot # 090401 (expiration Mar 2011)
- Lot # 090511 (expiration Apr 2011)
- Lot # 090602 (expiration May 2011)
- Lot # 090616 (expiration May 2011)
Immediately quarantine and avoid administering the affected product. Before administering any parenteral drug product, inspect product for particulates and color changes; do not administer if any are present. Cumberland Pharmaceuticals is working with wholesalers on product returns and credits. Healthcare providers should contact their wholesalers to return affected product. To report adverse effects from the use of any of the recalled lots, contact Cumberland Pharmaceuticals at email@example.com, 1-877-484-2700 (phone), or 1-866-438-2372 (fax); or report adverse events to FDA’s MedWatch program.
Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
- Wholesaler Letter and Return Form
January 3, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.