FDA Warns Against Use of 3 Recalled IV Medications

[vibha naik]

The US Food and Drug Administration (FDA) is warning healthcare professionals not to use intravenous versions of metronidazole, ciprofloxacin, and ondansetron manufactured by Claris Lifesciences after receiving reports of 2 contaminated intravenous bags.

The FDA stated that it received reports of floating white matter in 2 bags of Claris intravenous medications — 1 involving metronidazole, the other ondansetron. Microbiological analysis identified the substance in the metronidazole bag as a Cladosporium mold, which can cause infections in immunocompromised and other susceptible patients.

The metronidazole, ondansetron, and ciprofloxacin being recalled were all produced on the same manufacturing line in the company's facilities in Ahmedabad, India, where Claris is based. The company's Web site states that Claris has 5 manufacturing facilities in Ahmedabad, some of them approved by the FDA.

Sagent Pharmaceuticals, the distributor of metronidazole injection, does not know of any adverse events caused by its product.

The lot numbers under recall are A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016, and A000019. Sagent distributed these lots to hospitals, wholesalers, and distributors from February through May 2010.

http://www.medscape.com/viewarticle/722743

http://www.medscape.com/viewarticle/721982

 

Dr Vibhavari Naik, MD
Consultant Anesthesiologist,
Smile Train Project,
Nizams Institute of Medical Sciences,
Hyderabad, India.
E-mail: vib...@yahoo.co.in
Mobile: +91 9959189958

[nilesh tatar]

Have u thought of dropping down to nashik for conferance on 12-14 nov.

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Dr.Nilesh Tatar

[vibha naik]

Hi Nilesh, I dont really know if I am coming. Not yet scheduled that trip. I would love to come though. Lets see.

Hoping things are great at your end.

 

Dr Vibhavari Naik, MD
Consultant Anesthesiologist,
Smile Train Project,
Nizams Institute of Medical Sciences,
Hyderabad, India.
E-mail: vib...@yahoo.co.in
Mobile: +91 9959189958

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From: nilesh tatar <niles...@gmail.com>
To: isan...@googlegroups.com
Sent: Sat, 19 June, 2010 7:24:25 PM
Subject: Re: FDA Warns Against Use of 3 Recalled IV Medications