Johnson & Johnson recalling birth control pill Cilest
06 Jun 2013
US healthcare major Johnson & Johnson (J&J), which has been struggling with manufacturing issues since the past three years, is recalling about 32 million packages of its birth control pill Cilest in Europe, Asia and Latin America.
In its latest recall, Cilest, which is manufactured by J&J's subsidiary Janssen Pharmaceuticals Inc, is being recalled after it was found that a key ingredient was not being released into the body as specified.
J&J said that the problem does not affect the safety or efficacy of the prescription pills.
The recall includes all 179 lots, or batches, of Cilest that were distributed since 2011 in Europe, Asia and Latin America. Each lot contains about 180,000 monthly contraceptive packages.
The recall is not at the patient level, but pharmacies and distributors in countries like Argentina, Germany and Thailand have been asked to return unsold packages.
Cilest is not sold in the US.
The latest recall comes a month after J&J recalled children's Tylenol products in South Korea for containing an overdose of the medicine, and Indian health officials revoked its licence to manufacture cosmetics at a plant in Mumbai after finding that the company had used a dangerous and unauthorised process for sterilising baby powder (See: Johnson & Johnson's plant licence revoked on quality concerns).
J&J has issued a series of product recalls across a wide range of products over the past three years due to manufacturing-quality problems that have cost the company more than $3 billion.
It has recalled millions of bottles of over-the-counter products such as Motrin and children's Tylenol and other products like contact lenses, joint-replacement parts, surgical wound draining products, insulin pump cartridges, Rolaids Extra Strength Softchews among others.
Apart from this, the company is facing several lawsuits ranging from kickbacks to a company that dispenses drugs to nursing homes to faulty hip ASR implants.
J&J is operating under continuous scrutiny of the US Food & Drug Administration, the Congress and federal prosecutors over its several recalls, and has signed a consent decree with the US regulators to oversee some manufacturing.