TBA contamination prompts Topamax recall
pharmafile | April 18, 2011 | News story | Manufacturing and Production |Â Â Johnson and Johnson, recallsÂ
Another Johnson & Johnson business unit has decided to recall medicines because of a mouldy smell thought to be caused by contamination with TBA (2,4,6 tribromoanisole), a preservative used in wooden shipping pallets.
Ortho-McNeil Neurologics – part of Ortho-McNeil-Janssen Pharmaceuticals – is recalling around 57,000 bottles of its epilepsy treatment Topamax (topiramate), although it says only around 6,000 bottles remain in circulation.
Cases of TBA contamination continue to crop up, despite wide-ranging efforts by drugmakers to prohibit the use of TBA-treated wooden pallets for shipping medicines and storing empty bottles. It is thought that the chemical leaches from the wooden pallets into the bottles, and some manufacturers have opted to make greater use of plastic pallets.
“In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood,” said J&J in a statement.
“An internal investigation is underway with our suppliers to evaluate the potential source of this TBA issue.”
According to FDA’s latest enforcement report, other recent Class I pharmaceutical recalls include:
Metformin tablets: Mylan Pharmaceuticals has pulled over 500,000 bottles of its 500mg and 1,000mg metformin tablets, used to treat type II diabetes, because the affected lots may contain oversized and superpotent doses. The affected lots were made by contract manufacturer Matrix Laboratories.
Fentanyl patches: Generic drugmaker Actavis is recalling around 200,000 units of its Fentanyl Transdermal System 25mcg/h because they exceeded dissolution specifications in stability testing. The patches were manufactured by US company Corium International.
Creon capsules: Abbott Laboratories has initiated a recall of around 20,000 12-count bottles of its pancreatic enzyme replacement product Creon (pancrelipase), manufactured by Solvay Pharmaceuticals, because they may be subpotent.
Acetadote injection: Cumberland Pharmaceuticals has recalled over 20,000 vials of its injectable acetylcysteine product Acetadote, used to treat acetaminophen/paracetamol overdose, because of contamination with particulate matter.
Lisinopril tablets: Lupin Pharmaceuticals is recalling more than 14,000 bottles of its 30mg lisinopril tablets, indicated to treat high blood pressure, because the bottles may contain “foreign tablets”. The batch was manufactured at Lupin’s facility in Goa, India.
Phil Taylor
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