Serious Drug Recalls On the Rise

Serious Drug Recalls On the Rise

May 20th, 2013 // 1:00 pm @

Latest FDA and cGMP Compliance News

Due to an FDA crackdown on cGMP violations and an increasing shortage of many types of prescription drugs, we are not shocked to learn that we are seeing more FDA drug recalls in the first quarter of 2013.

We have seen 107 recalls as of the end of Q1. This is a 32% boost from the last quarter.

Due to the higher scrutiny of compounding pharmacies by FDA after the fungal meningitis scare last year, a compounding pharmacy set the 2013 record so far this year with a total of 13 recalls.

There have been more than 13 million unit recalls, which is an increase from 12 million at the end of 2012. Most of this was because of several big recalls, some of which were more than 1 million units each.

There were 14 Class I recalls in Q1, which was more than occurred in all of 2012. These are the most serious recalls because FDA says there is a ‘reasonable probability’ that using these drugs will cause a serious adverse event or even death.

There also were more Class II and Class III recalls in the last quarter than in every quarter last year. There were 62 Class II recalls and 31 Class III recalls. Six recalls were involving OTC drugs and three high volume drugs accounted for more than 80% of the total.

Most of the rest of the 107 other recalls dealt with prescription drugs, and 14 of them were Class I, 61 were Class II and Class III totaled 26.

67 of the recalls affected US customers around the country.

If you want to learn how your company can prevent and deal with a drug recall effectively, please review our upcoming Webinar from the CDRH recall branch chief, Rita Hoffman.


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