According to a document from the US Department of Health and Human Services (HHS), Actavis Totowa – makers of the recalled heart medication Digitek (digoxin) – were warned by HHS after an FDA inspection that took place in the summer of 2006.
Here is a link (PDF – Right Click and select ‘save link as’ for download) to the original warning letter from the the Department of Health and Human Services – of which the FDA is an agency / arm – to Mr. Divya C. Patel, President of Actavis Totowa, LLC on the date of August 15, 2006.
The FDA’s warning had to do with Actavis Totowa’s quality control processes and procedures and range from minor oversights to downright negligence. According to an article publish in 2007 on Entrepreneur.com:
“Numerous instances were observed where manufacturing process deviations occurred and in-process specifications were not met, yet there was no indication that action was taken promptly to investigate or to correct the deviations and the products were approved for release and distribution by the quality control unit, the [FDA] wrote.”
Digoxin was specifically mentioned in the warning letter, along with a long list of other pharmaceuticals:
“…cleaning validation was performed for the process trains without evaluating for sample recovery for numerous products, including: Amidal Nasal Decongestant; Amigesic Caplets, 750mg; Carisoprodol and Aspirin tablets, USP, 200mg/325mg; Carisoprodol tablets, USP, 350mg; Chlorzoxazone tablets, USP, 250mg and 500mg; Digoxin tablets, USP, 0.25mg.”
While “sample recovery” would not have had anything to do with Digitek tablets being manufactured at twice the dosage, it does show that Digoxin tablets were indeed being produced in a manufacturing environment with quality control issues that date back at least as far as two years ago! This is undoubtedly troubling news for people who have been taking the Digitek brand of digoxin tablets for years – especially those worried about the potential for permanent health problems that may be associated with long-term over dosage of the drug.
This warning from FDA implied serious concern over the quality of pharmaceutical drugs coming out of the New Jersey facility. Furthermore – and quoting from the Entrepreneur.com article – the FDA stated that Actavis Totowa should
“promptly initiate an audit program by a third-party having appropriate GMP expertise, to provide assurance that all marketed lots of drug products that remain within expiration have their appropriate identity, strength, quality, and purity.”
The bolded “strength” was added here for emphasis. This raises many questions, one of which is did Actavis Totowa initiate an audit program by a third-party as per the FDA’s recommendation?
I’m sure the attorneys will find the answer to that, and many other questions, soon enough.