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Paxil manufacturer GlaxoSmithKline is coming under fire after the US Food and Drug Administration (FDA) sent a warning letter to it about unacceptable manufacturing and communication procedures at a Cork, Ireland plant.
According to the release, the agency found contamination issues at the site and said that the manufacturer’s response “lacks sufficient corrective actions.” The plant reportedly makes active ingredients for the anti-depressant Paxil and has since recalled batches of the drug.
The FDA letter said that failure by the pharmacy to address issues at the plant could lead to the company banning materials produced at the site.
“We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact,” the agency wrote.
Injured by Paxil?
Contaminated drugs have been linked to personal injuries and death; keep in mind the outbreak of fungal meningitis cases in 2012 following the New England Compounding Center (NECC) steroid spinal injection recall.
Additionally, Paxil and other SSRI antidepressants have been linked to birth and development defects in children with the use of SSRIs during pregnancy. For more information about antidepressants and birth defects, talk with our SSRI lawyers by calling 888-841-9623 for a free initial review of your case.
Zoll & Kranz, LLC – SSRI attorneys
ZKB’s ‘Did You Know?’: SSRIs have been linked to cleft lip and palate among newborns.
Source: http://www.mmm-online.com/gsks-paxil-plant-cited-in-warning-letter/article/341261/
Michelle is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has been a plaintiff’s lawyer for the entirety of her practice – over 32 years. She devotes the majority of her time to complex consolidated litigation and class action including advocating for people injured by medical devices, prescription medications, or corporate negligence.
This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.
Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.
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