ALLEGAN – Perrigo Tuesday announced that the Detroit office of the Food and Drug Administration has arrived to reinspect its facilities for equipment failures last spring that included inadequate handling of metal shavings in a batch of bottles to be filled with Ibuprofen tablets.
In the case of the metal shavings, Perrigo caught the problem before the pill bottles hit store shelves. The entire lot was called back from distribution centers. The FDA criticized the handling of the problem because some of the affected product was allowed to leave the plant.
FDA inspections between Nov. 17, 2009, and Jan. 14, turned up the production problems, but it ruled that Perrigo’s Feb. 1 response “lacks sufficient corrective actions.”
Other lapses were in quality control, for mislabeling of several varieties of Milk of Magnesia. The labeling trouble led to recall of the cherry-flavored Milk of Magnesia in November, and the regular and mint-flavored variety two weeks later.
Pill-filling equipment also led to some brown tablets mixing in with orange caplets of Ibuprofen; the FDA criticized the company because it did not “thoroughly investigate.”
a>>
