News
Nearly 70% of Children’s OTC Medicines Made by McNeill Healthcare May Be Unsafe
Update: Reuters
“A Food and Drug Administration report released on Tuesday said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled last Friday.”
These are no longer brands you can trust, much less for your children. Clearly the problems cited above are easily seen and easily prevented. Dust, grime, ceiling holes and pipes patched with duct tape do not require a sophisticated plant inspector. Fixing them requires the owner spend the money on safety.
There is only one plant which produces babies’ and children’s Tylenol, Motrin and other OTC medicines for the youngest patients.
That one plant, this Washington Post story says:
- Lacked quality controls
- Used raw materials, contaminated with bacteria
- Failed to investigate customer reports of what appeared to be foreign bodies, black particles, in the productes
The FDA has found 20 problems at this plant.
“Federal officials said Tuesday that the sole plant that manufactures children’s and infants’ Tylenol, Motrin and other popular over-the-counter pediatric medicines lacked quality controls, used raw materials contaminated with bacteria and failed to investigate consumer complaints that some medicines contained black particles.
“The findings are serious,” said Deborah M. Autor, a senior official at the Food and Drug Administration, which documented 20 problems at the Fort Washington, Pa., plant owned by McNeil Consumer Healthcare, a division of Johnson & Johnson. She said the agency is weighing whether to take action against McNeil, pending the completion of its investigation.
“As FDA investigators were wrapping up a 10-day inspection of the plant last week, the company announced a voluntary recall of 43 over-the-counter pediatric medicines in the United States, its territories and nine other countries. The recall affects Tylenol, Motrin, Zyrtec and Benadryl, name brands widely used for pain, cold and allergy relief. Government sources estimate the recall could affect 70 percent of the market for pediatric over-the-counter medicines.”
Source: Washington Post, May 5, 2010
Source: Reuters, May 5, 2010