Following the detection of some contamination in intravenous metronidazole, ondansetron, and ciprofloxacin, FDA has issued a public health alert alarming the healthcare professionals not to use them.
The warning issued cover products sold under the labels of Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals.
According to the agency, reports of floating matter in IV bags produced by Claris Life sciences, in Ahmedabad, India have been received.
The alarm also states that foreign matter present in a sterile injectable product is not acceptable.
It was informed that one Claris customer reported white matter in a bag of metronidazole, which was then identified as Cladosporium mold. Another complaint was registered in ondansetron bag which is under analysis presently.
It has been noted by the agency that all products in the warning have been manufactured in the same plant and also on the same manufacturing line.
It is expected that Claris will soon be recalling a number of metronidazole and ondansetron, and other ciprofloxacin. The Company issued a recall earlier this month on selecting lots of metronidazole injection.
FDA then admitted that there was no report of injuries because of the products, as of now.
The reports of the investigation will be made public as soon as new information is collected, said FDA.



























