Actavis Voluntary Recalls Products for GMP Violations

August 14, 2008
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

Morristown, NJ, (Aug. 1)-Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, announced a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action following an inspection conducted by the US Food and Drug Administration earlier this year.

“The inspection at Little Falls revealed operations that did not meet the FDA’s or Actavis’ standards for good manufacturing practices,” said the company in a prepared statement. “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.”

Approximately 55 products are being recalled. A listing of the affected products may be found by a company listing and in an FDA enforcement report (July 30, 2008).

The following Actavis Totowa products are not manufactured at the Little Falls facility and are not affected by the recall: amlopidine besylate tablets, desipramine HCl tablets, finasteride tablets, irinotecan HCl injection, ondansetron HCl tablets, and orphenadrine citrate ER tablets.The recall is limited only to the Actavis Totowa products manufactured in the Little Falls facility. Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic, Actavis Mid Atlantic LLC, or Actavis products manufactured in other facilities are not affected by the recall.

The company said, “We are in the process of implementing corrective actions at the Little Falls facility and are working quickly and carefully to return products to the market. We cannot provide specific dates at this time,” as to when the products will return to the market.

The current recall is the third recall by the company this year. In April, Actavis Totowa initiated a Class 1 nationwide 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.