UPDATED: Janssen recalls 13,500 bottles of Xarelto because of contamination

Johnson & Johnson's ($JNJ) Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination discovered in a sample.

According to a recall notice in the latest FDA Enforcement Report, the drugmaker said that it confirmed that a sales sample of the drug was contaminated after a customer complaint, and so initiated a nationwide, voluntary recall. The company reported that the product came from a plant in Gurabo, Puerto Rico. The plant was among four on the island that J&J slated two years ago for $225 million in upgrades.

In an emailed statement, Janssen said, "Janssen is committed to ensuring the quality of its products.  We received a complaint involving one bottle of a XARELTO sample, and therefore are recalling the entire lot.  All XARELTO dosage strengths remain available for patients and product obtained at a pharmacy is not impacted.

The unit had a similar issue a year ago when it recalled 5,000 vials of Risperdal Consta, a long-acting injectable version of the antipsychotic pill Risperdal, after a sample bottle was found to be contaminated with a common mold.

J&J has had significant success with Xarelto, which came to market in the U.S. three years ago behind Boehringer Ingelheim's Pradaxa, but which has since eclipsed it in sales. A week ago, the drugmaker reported that sales of the drug, which it developed with Bayer, were $414 million in the third quarter, up 68% from the same quarter a year ago. The two recently said they would expand Xarelto research as a treatment for acute coronary syndrome (ACS) and other conditions.

- here's the notice

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.