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Paul Kiesel
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Associated Press: KV Pharmaceutical and Ethex Recall Morphine Sulfate Tablets and 17 Other Generic Products Due to Potential Life Threatening Consequences from Oversized Tablets

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On Friday, November 7, 2008, the Associated Press reported that Ethex Corporation, a manufacturer of the pain medication Morphine Sulfate, is voluntarily recalling five of their generic drug brands due to reports of tablets being as much as twice the size and potency as the labeled active ingredient levels suggests.

Morphine Sulfate is one of the five generic drugs that Ethex is recalling. However, this is not the first recall that’s been issued on Ethex Corp.’s Morphine Sulfate drug this year.

On June 10, 2008 the FDA issued a MedWacth E-mail Alert on Ethex Corp.’s "Morphine Sulfate 60 mg Extended Release Tablets – Recall of a Single Lot to a Report of a Tablet with Twice the Appropriate Thickness." The FDA warned then that any consumers that begin or continue to take this drug are at the risk of morphine overdose which could lead to breathing problems, erratic behavior, seizures, low blood pressure, nausea, vomiting and even death.

A few days after the FDA issued its MedWatch Alert, Ethex expanded its morphine pill recall to include specific lots of morphine sulfate 60 mg extended release tablets and of 30 mg tablets. These recalled lots were distributed between June 2006 and May 2008.

On October 15, 2008, Ethex released a voluntary recall to the consumer level of three specific lots of dextroamphetamine sulfate 5mg tablets, due to the presence of oversized tablets being reported by two pharmacists. A second recall on Morphine Sulfate was issued three weeks later and Ethex expanded this recall effort to include Propafenone HCI, Isosorbide Mononitrate and Dextroamphetamine Sulfate, which are all manufactured under the brand name "ETHEX."

The Morphine Sulfate tablets that have been recalled have labeled potency levels of 15mg, 30 mg, and 60 mg tablets (see below for specific lots).

In all, over 18 generic and non-branded products have been recalled in 2008 by Ethex and/or its parent company KV Pharmaceutical.

No report of any oversized tablets from any of the lots of the products involved in these June, October and November recalls has been received by ETHEX from any wholesaler, retailer, consumer or caregiver.

We are in the process of compiling all of the lot numbers and product descriptions for all 18 drugs that have been recalled from June through November 2008.

Below is a list of the lots involved in the recall that were shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “331” with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “332” with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “333” with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed “E” bisecting “30” on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed “E” bisect “60” on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with “15” on one side and an “E” on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a “15” on one side and an “ETH” on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with “30” on one side and an “ETHEX” on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed “ETHEX” and “312” on one side and double-scored on the other side.