John LaRocca, general counsel of Actavis Inc, Totowa’s parent company, told in-PharmaTechnologist.com that the move is “part of the firm’s ongoing compliance initiative and was not as a result of any health and safety concerns related to the products.”
LaRocca added that a Food and Drug Administration (FDA) inspection had revealed several documentation issues that were not compliant with either current good manufacturing practice (GMP) standards or those applied by the Actavis group as a whole.
In April, Totowa withdrew all batches of the cardiac drug Digitek (digoxin) that had been produced at the plant after tests revealed that the tablets contained double the amount of active pharmaceutical ingredient (API). The pills, which were to be sold by US drug giant Mylan, had been made at the incorrect thickness.
LaRocca explained that while this week’s decision was a continuation of the April recall, the newly withdrawn products posed no threat to public safety unlike Digitek which had presented a slight toxicity risk to renally-impaired patients, prompting the firm to remove it immediately.
LaRocca declined to comment about the likely financial impact of the recall on the Actavis group.
Drugs included in the recall can be viewed at the FDA website via the following link: http://www.fda.gov/oc/po/firmrecalls/actavis08_08.html
Previous FDA criticism
The Little Falls plant, which was acquired as part of Actavis’ $500m (€322.7m) takeover of Amide Pharmaceuticals in 2005, has had a chequered manufacturing past.
A little over a year ago, for example, Totowa was sent a warning letter by the FDA after an inspection revealed that it had produced “adulterated” drugs. The agency specifically criticised the quality control measures in place at the site, which it said had failed to reliably establish the identity, strength, quality and purity of some medicines.
The inspectors also noted a lack of investigation of out-of-specification test results, as well as insufficient documentation of the results. Subsequently, the firm said that all of the identified issues had been addressed to the FDA’s satisfaction.