GMP Tips - Avoiding Recalls - August 18, 2008

Actavis Totowa LLC just announced a voluntary recall of all drug products manufactured at its Little Falls, New Jersey, facility. This is a voluntary action following an inspection conducted by the US Food and Drug Administration earlier this year. Approximately 55 products are being recalled.

According to a statement from the company, “The inspection at Little Falls revealed operations that did not meet the FDA’s or Actavis’ standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.”

The current recall is the third recall by the company this year. In April, Actavis Totowa initiated voluntary recall of “Digitek” (digoxin tablets, USP, all strengths) for oral use. That recall was due to the possibility that tablets with double the appropriate thickness may have been commercially released and that the tablets may have contained twice the approved level of active ingredient.

In March, Actavis’ subsidiary Actavis South Atlantic LLC recalled fentanyl transdermal system CII patches sold in the United States. The recalled patches were manufactured by Corium International (Menlo Park, CA), a contract manufacturer for Actavis. The fentanyl transdermal system patches recalled may have had a fold-over defect that has the potential to cause the patch to leak fentanyl gel. As a precaution, Actavis recalled the products.

GMP Training Tip

Use this example in your GMP training sessions. If you produce tablets, ask the question, “How could they have produced, tested, approved, and shipped tablets that were DOUBLE the appropriate thickness?" and discuss answers.

Discuss the impact of recalling 55 products. How will this affect the company, the workers, their reputation, their future sales?

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