HIV drug Prezista recalled on TBA contamination
pharmafile | May 17, 2011 | News story | Manufacturing and Production |Â Â HIV, Johnson & Johnson, Prezista, manufacturing and production, recallsÂ
Johnson & Johnson has recalled 11,700 bottles of its HIV treatment Prezista after consumer reports of a mouldy smell caused by contamination with 2,4,6 tribromoanisole or TBA.
TBA contamination has been the cause of a number of J&J product recalls in the last couple of years, and has been was traced to plastic bottles and ultimately, to wood treated with a halogenated phenolic preservative which was used to manufacture pallets on which the bottles were stored. Other companies affected by TBA contamination issues include Pfizer and Depomed.
The latest recall of Prezista (darunavir) affects five batches of the antiretroviral therapy in 400mg and 600mg strengths which were made at a J&J plant in Puerto Rico and have been distributed in the UK, Ireland, Germany, Austria and Canada, according to J&J’s Janssen-Cilag International unit.
J&J said there is no evidence that TBA causes side effects at the levels encountered and has warned patients not to discontinue treatment with Prezista.
“In January 2010, Janssen 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 the firm in a statement.
“An internal investigation is underway with suppliers to evaluate all potential sources of TBA.”
Prezista is on its way reaching blockbuster status in 2011, posting sales of $266 million in the first quarter of the year, up 42% on the same period of 2010.
Other recalls reported this month include:
AstraZeneca’s Zoladex (goserelin acetate): A batch of prostate cancer drug Zoladex 3.6mg in single-dose syringe applicators has been recalled in the UK because of potential packaging defects. The integrity of the pouches used to house the syringes is suspect, and could affect the shelf-life of the product, according to the MHRA.
Luitpold Pharmaceuticals’ Sodium Chloride Injection: Nearly 400,000 bottles of this bacteriostatic injection in 30ml multiple-dose vials have been recalled in the US because some may be contaminated with visible particles.
Bristol-Myers Squibb’s Coumadin: 1,000-count bottles of BMS’ anticoagulant Coumadin (warfarin) 5mg tablets have been recalled in the US because they may contain superpotent doses of the active ingredient.
American Regent’s Caffeine & Sodium Benzoate Injection: One lot of vials of this treatment for breathing problems caused by overdoses of drugs or alcohol has been recalled because some may contain contaminating particles which could cause side effects in patients, says the company.
Phil Taylor
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