McNeil Says Supplier Snafu Prompts 200,000-Bottle Recall of Children’s Motrin

Citing supplied shipments of tainted ibuprofen, McNeil Healthcare is recalling three lots of children’s Motrin — about 200,000 bottles — due to potential plastic particulates, the latest chapter in a long history of quality issues for Johnson & Johnson’s OTC subsidiary.

The market correction, which pertains to a concentrated, berry-flavored version of the product, follows the discovery of tiny plastic particles about the size of a poppy seed in a different, unreleased product lot during manufacturing, the company said late Sept. 6.

“Out of an abundance of caution, McNeil is voluntarily recalling the three lots released to the market made with the same batch of [ibuprofen],” it added. “McNeil has worked with the third party to ensure that corrective measures are currently in place and are effective.”

The likelihood of adverse events arising from particles is “not likely,” the company said.
McNeil quality issues have previously prompted regulatory enforcement. The state of Oregon sued McNeil and J&J a few years ago over a “phantom recall” of Motrin, alleging McNeil failed to notify retailers and consumers of possibly defective products and tried to “quietly remove Motrin containers from store shelves.”

McNeil continues to operate under a consent decree it entered into a few months after the lawsuit was filed. The decree brought an end to one of McNeil’s three U.S. facilities. Production volume at its remaining plants in Lancaster, Pa., and Las Piedras, Puerto Rico, has been negatively impacted by the decree’s requirement that a third party review records for selected  batches, according to J&J’s 2012 annual report.

The recalled Motrin was manufactured at J&J’s Beerse, Belgium, plant, a spokesperson said Monday. The McNeil representative declined to reveal the ibuprofen supplier.
The recall is a hiccup in J&J’s efforts to restore consumer confidence in its OTC brands. That effort is being led by former Bayer exec Sandra Peterson, who took over as head of J&J’s consumer group business in December.

During a July 16 conference call to discuss J&J’s second quarter earnings, Peterson said OTC remediation is expected to continue apace in the near-term, and that the drugmaker expects to deliver a “reliable and consistent supply” of three-quarters of its OTC brands by the end of the year.

Despite the manufacturing setbacks, J&J’s OTC segment continues to be profitable. U.S. sales of OTC drugs reached $290 million in the second quarter of 2013, reflecting a 17-percent increase over the same quarter in 2012.

The recall comes in the midst of heightened FDA scrutiny on supplier oversight. The agency released draft guidance earlier this year providing recommendations on how companies can craft a quality agreement with a contract manufacturer.

Maintaining the integrity of batches of product is just one area of FDA compliance. There are many more areas that you need to know about to ensure that your product gets to market as easily as possible. With FDA Compliance Boot Camp 2013 Validation, Data Security, Quality Risk Management, and Compliance Training, you’ll learn how to keep all of your compliance bases covered. Sign up to attend the conference.