Another "Double-Dose" Pill Problem Demonstrates How And Why The Digitek Recall Is So Unusual

June 2008 Drug Recall By ETHEX Is Similar To Digitek Recall, But Here The Drug Company Is Able To Provide Specific Information About Dates And Lot Numbers, Unlike Actavis

(Posted by Tom Lamb at DrugInjuryWatch.com)

A June 10, 2008 FDA MedWatch Email Alert had a familiar sound to those of us following the Digitek recall: "Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness".

But the similarity between this new morphine tablet recall and the Digitek recall announced in April 2008 ends with the "double-dose" defect involved because the ETHEX Corporation was able to pin-point when the manufacturing problem at their facility occurred, something Actavis Totowa apparently is still unable to do more than six-weeks after the drug company initially announced the problem with its UDL and Bertek Digitek (digoxin) tablets.

Here is an excerpt from the 2008 Medical Product Safety Alerts part of FDA's web site concerning this June 2008 morphine tablet recall:

ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual.

A June 9, 2008 Press Release from ETHEX provided these additional details:

The voluntary single-lot recall is due to a report that a tablet with as much as double the appropriate thickness was identified and the possibility therefore that there may be other similar oversized tablets that may have been commercially released in the affected lot. Such tablets may contain as much as twice the labeled level of active morphine ingredient. The product is a white oval tablet with "60" on one side, and "E" on the reverse.

In contrast, consider how Actavis has failed to provide specific information about the extent of their Digitek tablet manufacturing problem:

FDA Says It Doesn't Know How Long Defective Digitek / Digoxin Pills Were Sold

Extent Of Digitek Recall Remains A Mystery Ten Days Later; Patients Are Left In The Dark

Recall Notice For Digitek Marketed Under Bertek Label Goes Back To March 2006

Actavis Tells Us More, But Not Much More, About April 2008 Digitek Recall

Digitek Update May 2008: When Old News Is Better Than No News At All

At this late date, one has to suspect that Actavis is still unable to determine the extent of their New Jersey plant manufacturing problem that led to its April 2008 all-lot recall of Digitek pills.

If Actavis can tell us the date-range, at least, when patients might have been ingesting a defective Digitek pill, numerous families around the country would very much like to have the benefit of this information in order to satisfy their concerns.