CLASS I DRUG RECALLS ON THE RISE
CDER performed 45 Class I recalls of human drugs deemed to have "very serious potential to cause harm, injury or death" in the last fiscal year, according to Joe Famulare, acting deputy director of CDER's Office of Compliance.
That number is "very significant," since many years there are only one or two such recalls, Famulare told attendees at the 2006 Generic Pharmaceutical Association Fall Technical Conference Oct. 19.
The period from Oct. 1, 2005, to Sept. 30, 2006, also saw 193 Class II recalls of drugs deemed "to have the potential to cause harm," but where the damage is reversible, and 128 Class III recalls, which are generally for labeling violations and do not pose a direct health hazard, Famulare said.
These recall numbers include drugs that have not yet received full approval but for which new drug applications or abbreviated new drug applications have been submitted, and certain biologics that CDER also regulates, Famulare said.
Some of the top reasons for recalls in fiscal 2006 were:
Subpotency in single-ingredient drugs;
Impurity;
Defective containers;
Nonsterile products, which are a particular problem for goods "manufactured in nontraditional settings;" and
Superpotency.
CDER officials are finding that certain companies have major problems with current good manufacturing practices, which "results in our having to remove whole classes of products," Famulare said.