Irish Medicines Board confirms recall of anti-depressant drug manufactured by GSK

According to RTE News

The Irish Medicines Board has confirmed that a number of batches of an anti-depressant drug being recalled by GlaxoSmithKline had been placed on the Irish market. The recall was ordered following a warning from the US Food and Drug Administration. It said the active ingredient for the drug, manufactured in Co Cork, may have been contaminated with a solvent from a pharmaceutical waste tank.

The FDA issued a warning letter on March 18th which can be found here:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390435.htm

It states the following (please note, the (b)(4) code is a redacted version of the actual product code):

Your firm discovered that the (b)(4) used to manufacture (b)(4) batches of (b)(4) and (b)(4) batches of (b)(4)was contaminated with material from your pharmaceutical waste tank, which contained APIs, intermediates, and solvents. Examples of chemicals that are collected in the waste tank include (b)(4). Your firm became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of (b)(4) manufactured using the contaminated solvents on April 19, 2013. Your firm distributed (b)(4)shipments of (b)(4) potentially contaminated (b)(4) batches after becoming aware of this significant deviation. In contrast, (b)(4) batches made with the contaminated (b)(4) were rejected.

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posted by drcooke on Monday, April 7th, 2014 at 10:50 am in cGMP & QC

tags: 483 warning letter, GSK, HPRA, IMB, Recall

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