ETHEX Corporation Expands Its Voluntary June 2008 Recall Of Morphine Sulfate Extended Release Tablets

Recall Now Covers 30 mg And 60 mg Tablets Made During June 2006 To May 2008 Period Due To The Potential For Oversized Tablets

(Posted by Tom Lamb at DrugInjuryWatch.com)

As we reported recently, on June 10, 2008 the FDA issued a MedWatch Email Alert, "Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness".  At that time, the ETHEX Corporation seemed to think that its manufacturing problem was limited to the period April 16 to April 27, 2008 and restricted to 60 mg tablets, only.

A few days later, however, ETHEX greatly expanded their morphine pill recall as detailed in the company's June 13 Press Release:

ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets.  Oversized tablets may contain as much as two times the labeled level of active morphine sulfate.  The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008.  The lot numbers involved in the recall are:

Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04:  Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284

Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04:  Lots 91762 (previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333, 83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272, and 91763 through 91765.

Whereas previously this ETHEX morphine pill recall seemed to be narrow and specific, it now appears that the ETHEX recall may be more like the Digitek problem, where Actavis issued a recall for all lots of its generic digoxin pills manufactured from March 2006 to April 2008.

Returning to the ETHEX June 13 Press Release, there are indications that the drug company is still struggling to determine how and when the manufacturing process was such that oversized tablets were being produced and released:

The voluntary recall follows a report that a tablet with as much as double the appropriate thickness was identified in a previously recalled lot.  No oversized tablets have been identified in any additional distributed lot of these products and, based on our investigation, there are likely to be few, if any, oversized tablets in the recalled lots.  The decision to recall the additional lots listed above has been taken as a responsible precaution because of the possibility that there may be oversized tablets in those lots.

If any patients or their families have questions about this June 2008 morphine sulfate tablet recall, they can call ETHEX Customer Service (800-321-1705) or, if more appropriate, they can contact their doctor, the dispensing pharmacy / pharmacist, or some other health care provider.

We will continue to monitor developments concerning this ETHEX recall of morphine pills.