Cumberland announced a recall of six lots of Acetadote (acetylcysteine) injection, 20% solution (200mg/mL) in 30mL 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.
The following lots are being recalled:
- 090304 (expiration Feb 2011)
- 090331 (expiration Feb 2011)
- 090401 (expiration Mar 2011)
- 090511 (expiration Apr 2011)
- 090602 (expiration May 2011)
- 090616 (expiration May 2011)
Acetadote is indicated to minimize hepatic injury after acetaminophen overdose.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238494.htm.