MALLINCKRODT QUALITY CONTROL PROCEDURES FOR BULK ACETAMINOPHEN INADEQUATE
This article was originally published in The Tan Sheet
Executive Summary
MALLINCKRODT QUALITY CONTROL PROCEDURES FOR BULK ACETAMINOPHEN INADEQUATE at the company's Raleigh, N.C. facility, FDA charged in Nov. 18 warning letter. Mallinckrodt has "failed to implement appropriate quality controls for the testing of finished acetaminophen prior to release for distribution," the letter maintains. The bulk acetaminophen was intended for incorporation into a finished product in combination with hydrocodone bitartrate.