Withdrawal of Tampered Products Won’t Necessitate Recall: FDA

Revisions to the FDA’s Regulatory Procedures Manual don’t add any clarity on when a product removal is a recall and when it’s a market withdrawal, attorneys say. The revised RPM, issued Oct. 23, defines “market withdrawal” to include removal of a product that has been tampered with when there is no evidence of manufacturer or distributor responsibility. “The district should recommend the action be designated as a market withdrawal since, although the situation may present a health hazard, there is no one identified as responsible for the violation,” the manual says.
Devices & Diagnostics Letter