“The mold was detected during the product’s 12-month stability testing point, which is a routine testing process,” J&J spokeswoman Robyn Frenze told In-Pharmatechnologist.com.
She added that the mold found in the sterility test, Alternaria alternata, is “commonly found in the environment.” But she did not reveal how Janssen would keep future product from contamination of the same mold, though she did say there will be “no manufacturing delays.”
Both she and the letter to physicians said there are “no trends or patterns of clustering of adverse events of infection associated with the identified lot.”
“It is estimated that fewer than 5,000 dose packs remain in the market. There will be no supply interruption,” Frenze said. The injection also should not be confused with J&J’s oral Risperdal, she clarified.
This injection recall comes just five days after J&J’s McNeil Consumer Healthcare Division voluntarily recalled about 200,000 bottles of concentrated Motrin infants’ drops the after the company found plastic particles about 1 mm in size.
The particles, which originated from a supplier’s ibuprofen, were found in a different product lot during manufacturing that was not released. McNeil is recalling the three lots released to the market made with the same batch of active ingredient.
McNeil has worked with the supplier to add corrective measures, the company said.
Meanwhile, J&J has sued Ben Venue Laboratories because of a dispute over manufacturing the cancer drug Doxil and whether it must be submitted to arbitration, according to Bloomberg News.
Ben Venue was hired as the sole manufacturer of Doxil in 1995 but manufacturing was shut down at the CMO’s Ohio plant after European and US regulators questioned the quality of the products being made at the facility.
J&J officials are asking Delaware Chancery Judge Leo Strine to order Ben Venue to honor its agreement to submit disputes over Doxil production to an arbitrator.
India’s Sun Pharmaceuticals Industries Ltd. began selling a generic form of Doxil in February 2012.