J&J recalls 32 million contraceptive packs
pharmafile | June 5, 2013 | News story | Manufacturing and Production |Â Â Cilest, J&J, JJ, recallÂ
Johnson & Johnson has announced a 43-country recall of its oral contraceptive Cilest and suspended production of the drug because of a quality defect.
The recall is taking place after a routine lab test of Cilest (ethinylestradiol and norgestimate) found that the norgestimate ingredient did not meet specifications and was not being released in the body as expected.
In total, the recall covers all 179 lots of Cilest distributed since 2011 in Europe, Asia and Latin America, which together account for more than 32 million packs of the product. The contraceptives are not sold in the US.
J&J claimed that the problem should not affect the safety or efficacy of the product and there is only a ‘very low’ risk that it could result in unplanned pregnancies, according to a Pharmalot report.
The news comes as J&J continues to struggle with manufacturing problems that have plagued its operations in the last few years, with three of its plants currently operating under a FDA consent decree.
Moreover, while these initially seemed to be confined mainly to its McNeil Consumer Health operations, quality issues have also cropped up in J&J’s medical device unit – with an insulin pump recall announced just last month – and now its prescription pharmaceuticals business.
At the moment the company is facing possible criminal charges in South Korea over quality lapses that led to over-strength paediatric Tylenol (acetaminophen) syrup being released into the supply chain.
J&J says that the recall is being conducted on Cilest packs from pharmacies and wholesalers, but is not being extended to include packs that remain in consumers’ hands. Around 800,000 packs are thought to be available for sale at the moment.
Meanwhile, the manufacturing facility in Schaffhausen, Switzerland, that produces Cilest – which is part of the group’s Cilag AG subsidiary – will no longer release any shipments until the problems are investigated and resolved.
Cilag said last year it would rein back production of active pharmaceutical ingredients (APIs) at Schaffhausen dramatically by 2015, focusing only on high-value APIs such as high-potency compounds, because of dwindling demand for ingredients made there.
Phil Taylor
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