Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.
Makers of Digitek, a heart medication now subject to recall, were warned of various problems by letter after an FDA inspection that took place in the summer of 2006.
The original warning letter, see here, from the Department of HSS to the President of Actavis Totowa, LLC is dated 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 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.”
Digitek was included in the warning letter, in its generic name "Digoxin":
“…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 this does not relate directly to the oversized pill that prompted the recall, it does show that the manufacturing oversight for digitek was lacking. It has been suggested that the company should have promptly initiated 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. Investigations that will be undertaken by law firms such as Levin Papantonio will seek to determine whether appropriate measure were initiated by the company following this warning letter.
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