- The FDA has confiscated all pharmaceuticals and pharmaceutical ingredients from a Michigan-based manufacturer, Caraco Pharmaceutical Laboratories Ltd, due to the company’s ongoing failure to meet the FDA’s Good Manufacturing Practice requirements.
- Caraco’s inability to observe these requirements may result in a shortage of a pain medication called choline magnesium trisalicylate. However, the number of patients who use this pain medication is relatively small.
- Despite several notifications from the FDA, Caraco continued to manifest poor control over their raw materials and tablet manufacturing processes, showing higher than average variability.
- The FDA’s intervention bans Caraco from distributing any drugs until they can provide evidence of adherence to good manufacturing practices.
- The aim of this intervention, according to the FDA, is to get Caraco back up and running safely while helping them break a cycle of substandard performance.
The U.S. Food and Drug Administration’s recent confiscation of all pharmaceuticals and pharmaceutical ingredients from a Michigan-based manufacturer could potentially result in a scarcity of a specific pain reliever, the agency announced.
A National Action Against Drug Manufacturer
The FDA authorized U.S. Marshals to confiscate articles from facilities operated by Caraco Pharmaceutical Laboratories Ltd situated in Detroit, Farmington Hills, and Wixom, Mich. Caraco Pharmaceutical Laboratories Ltd is a generic drug producer renowned for its cardiac, psychiatric, and pain medications.
“The operation was due to the company’s consistent inability to observe the FDA’s prevailing Good Manufacturing Practice requirements that ensure the drug’s quality,” expressed Deborah M. Autor, the director of FDA’s Office of Compliance, Center for Drug Evaluation and Research during a Thursday afternoon meeting.
Potential Impact on Consumers
Caraco manufactures 33 different drugs that may be implicated in this incident, Autor reported. However, she ensured the public that consumers should continue to use any Caraco-manufactured drugs that they might still possess.
The confiscation may induce a shortage of a pain medication known as choline magnesium trisalicylate. Nevertheless, this drug is utilized by a relatively small patient populace, and they can seek alternatives by consulting their respective physicians, Autor advised.
Regulatory Enforcement by the FDA
The FDA implemented this measure due to Caraco’s constant inability to satisfy the FDA’s Good Manufacturing Practice necessities despite several notifications. The FDA’s intervention forbids Caraco from distributing drugs until the company offers the agency evidence that it is adhering to good manufacturing mandates.
Commencing in January 2009, Caraco voluntarily recalled medications considered flawed by the FDA. The voluntary recalls were caused by manufacturing defects, which included oversized pills and potential inaccuracies in the drug contents. In May 2009, the FDA reinspected Caraco and discovered continued contraventions of good manufacturing practices.
“Caraco manifested substandard control over their raw materials required for product manufacturing,” commented David Jaworski, a consumer safety officer in the FDA’s Office of Compliance, Center for Drug Evaluation and Research. “Moreover, the company’s tablet manufacturing processes showcased a higher than average variability, which we believe has not been sufficiently addressed,” he observed.
The Way Forward
“Our intention is to get Caraco operational safely,” Autor stated. “Confiscations often result in significant modifications from corporations which assist them to break a cycle of substandard performance,” she highlighted.
For more details concerning the recalled Caraco products, visit the U.S. Food and Drug Administration here.