When Will We Learn The Real Extent Of Generic Drug Recalls By Actavis And ETHEX

Numerous Instances Where Out-Of-Spec Oversized Pills With Double The API Dose Are Produced: How And When Did This Happen?

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late April 2008, when the Digitek recall was announced by Actavis, most were surprised to hear that so-called "double-dose" pills were being produced by a drug company here in the U.S. 

But since then we have learned about several more instances of out-of-spec, oversized pills with double the dose of their respective active pharmaceutical ingredients (API), most recently the November 2008 (third and latest) recall by ETHEX involving these generic drugs:

Propafenone HCl Tablets: 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets: 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets: 15 mg
Morphine Sulfate Immediate Release Tablets: 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets: 10 mg  

Other 2008 recalls by Actavis and ETHEX involving possible double-dose pills include:

• August 2008 Actavis Recall Of All Drugs Manufactured At Its Little Falls, NJ Plant

• A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.  (October 2008)

But we have had no explanation from Actavis, ETHEX, nor the FDA about what went wrong at these generic drug manufacturing plants such that we are able to know the extent to which these various defective pills were available for ingestion by unsuspecting patients.  That is, there has been little if any real information about the quantity of double-dose Digitek pills, for example, and when in time specifically those oversized pills were being produced by Actavis at its Little Falls, New Jersey facility.

In a November 10, 2008 article, "Big pills big problem for Ethex?", reporter Gareth Macdonald suggests that it may be difficult for us to learn how and when these generic pills were actually produced by ETHEX, and seemingly the same pertains to the Actavis recalls:

Details of any specific problem have not been released, making it difficult to ascertain if the oversized pills are a result of a manufacturing deficiency or simply that more out-of-spec tablets are being detected than previously as the sensitivity of analysis methods continues to improve.

Either way however, the growing safety focus following recent high-profile problems with branded products, generics and APIs is likely to result in the identification of more out-of-spec tablets as levels of regulatory scrutiny are increased.

Of course, there is always the possibility that FDA and Actavis will issue a Digitek update, for example, someday.  But with the passage of time since this FDA Class I Digitek recall was first announced in April 2008, it seems increasingly unlikely that Actavis or the FDA will be providing any clarification about the extent (in terms of quantity and time) of double-dose Digitek pills that were distributed to unsuspecting patients.

In early October 2008 Representatives John D. Dingell (D-MI) and Bart Stupak (D-MI) announced that Congress is investigating the Digitek recall to learn what the FDA knew about manufacturing problems at the Actavis facility in Little Falls, N.J.  Perhaps this investigation will yield some answers for us about the quantity and time questions.

Lastly, there will be what is called "discovery" in the Digitek litigation intended to figure out what led to the double-thickness problem at the Little Falls Actavis facility.  And, in the end, it may be this discovery process in the Digitek litigation is the only way that we will eventually learn the how and the when of what happened, there.