The Therapeutic Goods Administration of Australia (TGA) is investigating a potential link between AFT Pharmaceuticals propofol products and reported cases of sepsis.
There have been reports of eight patients having developed sepsis following administration of 1% propofol injection.
This has prompted the TGA to advise health care providers of the potential risk of contaminated batches.
In consultation with the TGA, the Australian distributor of Provive MCT-LCT 1% (propofol 1%) emulsion for injection in 20 ml vials (ARTG 162318), AFT Pharmaceuticals, has quarantined two batches due to potential contamination with Ralstonia pickettii. The affected batch numbers are:
- A030906 (expiry date 08/15)
- A030907 (expiry date 08/15).
At this time, no batches of any of the drugs listed below are subject to a recall. For more infectious disease news and information, visit and “like” the Infectious Disease News Facebook page.
Ralstonia pickettii are Gram-negative bacteria. It may take several days for a blood culture to become positive and may be difficult for a laboratory to identify. Possible initial identifications include Stenotrophomonas, Burkholderia and Pseudomonas species of bacteria.
The TGA investigation is ongoing.