And the posturing continues. The healthcare giant last week sent an unsigned note to its employees, essentially, reiterating remarks made to Congress and journalists about its efforts to recall Motrin from stores last year amid a widening quality-control problem.

The corporate verdict: J&J did nothing wrong, although Congress maintains J&J contractors conspired with execs from J&J’s McNeil Consumer Healthcare unit to disguise a recall and mask serious problems at a Pennsylvania plant that is now under wraps (see this and this). Just the same, J&J continues to maintain it had nothing to do with a memo distributed by its contractors instructing employees not to mention a recall.

J&J argues it was only conducting an audit to determine if a recall of two lots of Motrin was necessary and that agency officials were informed of its doings. To underscore that point, a couple of internal J&J emails found their way into this item from Portfolio.

In any event, the employee memo concludes: ‘McNeil was transparent with the FDA and kept the agency informed about the removal of affected lots of Motrin IB from the market. Simply put, there was no phantom recall.” The goal was to minimize disruption and confusion among retailers, although there was no mention about concern for consumers. The memo also stated McNeil notified wholesalers prior to the final removal from stores, telling them “explicitly” it was done due to a failure to meet performance standards. We asked J&J about the timing - when were wholesalers notified, but J&J declined to respond.

This is an excerpt from the memo: “Now that those documents have been submitted to the Committee, we can confirm what (Worldwide Consumer Health Group chair) Colleen (Goggins) told the Committee at the time: McNeil was transparent with the FDA and kept the agency informed about the removal of affected lots of Motrin IB from the market. Simply put, there was no “phantom recall.”

The objective was to remove the affected product in a quick and effective manner from a unique distribution channel – mainly convenience stores and gas stations – with as little disruption and confusion as possible among these retail partners and consumers.

Specifically, the information submitted to the committee confirms that:
· After discovering that two lots of Motrin were out of specification, McNeil contacted the FDA, informed FDA about its plans to survey stores and to remove the product, and regularly updated FDA on its progress.
· There was no patient health or safety risk, nor any consumer complaints. The reason for the recall was that McNeil internal tests showed that some tablets might not dissolve as quickly as intended.
· The memo that was of concern to the Committee entitled “CSCS Motrin Purchase Project,” did not come from McNeil. It was created without McNeil’s knowledge by a subcontractor with whom McNeil had no direct contact.

McNeil notified its wholesale customers prior to the final removal of product from store shelves, telling them explicitly that the affected lots were being removed because they did not meet performance standards.

McNeil hopes that the information sent to the Committee will clear up any misunderstandings about this issue. McNeil will continue to cooperate with the Committee and the FDA to address our shared concerns about ensuring manufacturing quality at McNeil and remediating all the issues that led to the recent recall. McNeil continues to work aggressively on its remediation planning and efforts. “