Overweight pills are making the news these days.
Barr Labs initiated a recall in mid-August for generic Adderall tablets that may contain too much of the active pharmaceutical ingredients dextroamphetamine and dl-amphetamine, posing a superpotency risk to users of the ADHD drug.
In addition, although recently given a clean bill of health following an FDA inspection, Mylan is nonetheless dealing with fallout from accusations in a local press report that the generics maker's manufacturing employees allegedly sidestepped drug quality controls, yielding medications out of spec for weight, thickness or hardness.
And the recall of Digitek in spring 2008 for possibly containing twice the approved level of digoxin has been followed by other digoxin brand recalls, most recently a version from beleaguered Caraco last May.
Pills become overweight when too much of the drug's API gets weighed out and put in the formulation, says Charlie Carney, a long-time GMP practitioner and consultant who is now an instructor for ISPE. "It doesn't usually lead to an incredibly large increase in mass because the pills are compressed to the same size. So they wind up having greater potency than intended."
It's a big issue that should automatically invoke an internal quality investigation, he says.
"Today, with computer controls, it's hard to hide facts. Whether the problem is found in house and the product is never distributed, an investigation and a fix are required. If it's caught by the FDA in an audit, a much bigger fix is required, sometimes involving retraining for operations personnel and even closure of the plant."
- see the Adderall recall release
- here's our earlier Mylan coverage
- here's the Digitek recall notice