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Fresenius Kabi Recalls Four Lots Of Benztropine Mesylate Injections

July 15, 2013

Fresenius Kabi Recalls Four Lots of Benztropine Mesylate Injections

In March, Med Prep Consulting Inc. announced the recall of a magnesium sulfate intravenous solution after traces of fungus were reportedly found in at least five bags of the solution. Although no infections among patients who had received the affected IV were reported, the contaminated solution posed a serious health risk. Early this month, a similar recall involving unwanted particles inside the packaging of a crucial medication was issued. Fresenius Kabi issued a nationwide recall involving four lots of Benztropine Mesylate injections, which is bottled in 2 mL vials.

The injections are being recalled “due to particulate matter characterized as thin colorless flakes that are visually and chemically consistent with glass delamination that were observed in reserve sample vials for the above-mentioned lots,” according to the recall letter issued by Fresenius Kabi. If administered, a tainted injection poses a safety risk to patients. For instance, there are case reports that suggest some life-threatening conditions, such as pulmonary embolism, can arise.

Benztropine Mesylate is traditionally used in the treatment of Parkinson’s disease and tremors that occur due to other medical conditions. According to the FDA, the drug is effective in “the control of extrapyramidal disorders due to neuroleptic drugs, except tardive dyskinesia.” The drug is packaged with either the “App” or “Nexus Pharmeceuticals” labels. Fresenius Kabi has not received any reports of patient reactions or customer complaints.

Fresenius Kabi has pulled distribution of the drug while it continues to investigate the issue. The company is notifying all customers who received the recalled drug and instructing them to return any unused vials to the company. Fresenius Kabi can be reached at 1-800-551-7176 or by email at appmedicalinfo@APPpharma.com.

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