Just days after its U.S. division recalled all of its <"https://www.yourlawyer.com/topics/overview/Actavis_Recall">generic drugs, Icelandic drug maker Actavis Group announced that its CEO is stepping down. However, in announcing the departure of RÃ³bert Wessman, the company made no mention of Actavis Totowa’s recent safety problems, which also included an April recall of Digitek tablets.
Instead, media reports say Wessman was stepping down to focus on his investment company Salt Investment, but will continue to have a seat on the board of Actavis. Actavisâ€™ owners apparently felt that Wessmanâ€™s interests in Salt Investment might draw his attention away from Actavisâ€™ daily operations.
Earlier this week, Actavis Totowa announced it as recalling all of the generic drugs made at its Falls River, New Jersey facility. The recall was prompted by a Food & Drug Administration’s (FDA) inspection at the facility which revealed that operations did not meet the agencyâ€™s standards for good manufacturing practices. Actavis Totowa is asking pharmacies, hospitals and retailers to return the affected prescription medications.
This week’s generic drug recall was only the latest of Actavis Totowa’s safety woes. In February 2007, the FDA issued a warning letter to Actavis Totowa following an inspection of the Little Falls facility completed in August 2006. The violations cited in that letter included: significant deficiencies in the company’s quality control unit; laboratory notebooks that did not include all raw test data generated during testing; failure to check for accuracy the inputs to and outputs from the “Total Chrom Data Acquisition System,” which was used to run the firm’s HPLC instruments; quality control failed to recognize that some tablets that did not meet in-process specifications; lack of adequate procedures for conducting bulk product holding time studies; cleaning validation studies were found to be inadequate; master and batch production and control records were found to be deficient; and equipment used in the manufacture of Benztropine Mesylate tablets and other drug products was not adequately qualified.
In the warning letter, the FDA stated that it had reviewed the firm’s corrective actions promised in a letter dated Aug. 29, 2006. The agency found that while corrections the firm promised in its correspondence appeared to adequately address many of the violations, the FDA reiterated its concern about the quality of drug products that were released from the facility under the serious lack of controls found during the inspection.
In April, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the FDA, the Digitek defect could cause serious and even fatal digitalis reactions in users. Some of the faulty Digitek involved in this earlier recall was made at the New Jersey facility.
The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports.