Morphine Sulfate

Additional Lots of Potentially Oversized Morphine Sulfate Tablets Recalled

November 7, 2008--ETHEX Corporation of St. Louis, MO has voluntarily recalled specific lots of Morphine Sulfate Extended Release (15 mg) and Morphine Sulfate Immediate Release (15 and 30 mg) Tablets due to the possibility that oversized pills containing twice the appropriate dose may have been manufactured and commercially released.  In June 2008 the company issued a recall of certain lots of its Morphine Sulfate Extended Release (30 and 60 mg) products because of the potential production of oversized tablets.

Morphine Sulfate is a prescription drug that is used primarily for the treatment and management of moderate to severe pain. Opioids such as morphine sulfate can have life-threatening consequences if overdosed.

In addition to the recalled Morphine Sulfate tablets, Ethex announced that it is also recalling specific lots of three other generic/non-branded products it manufactures due to the similar potential for oversized tablets:  Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, and Dextroamphetamine Sulfate Tablets. An overdose of any of these drugs can have serious health consequences. The lots involved in the November 7^th recall were all shipped prior to May 22, 2008.

On December 23, 2008 Ethex announced that it had also recalled a single lot of Hydromorphone HCI 2 mg tablets due to the possibility it may contain oversized tablets. Simultaneously, KV Pharmaceutical, Ethex’s parent company, announced a voluntary suspension of all shipments of its FDA approved drugs in tablet form. 

Morphine Sulfate Extended Release Tablets (15 mg) and Morphine Sulfate Immediate Release Tablets (15 and 30 mg)

Lot Numbers involved in the November 2008 recall:

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.  The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse.

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.  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.

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. 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.

Morphine Sulfate 60 mg and 30 mg Extended Release Tablets

June 13, 2008—ETHEX Corporation expanded its earlier (June 9, 2008) voluntary recall of one lot of 60 mg Morphine Sulfate tablets to include additional specific lots of 30 mg and 60 mg Morphine Sulfate Extended Release tablets due to the potential that oversized tablets containing twice the labeled level of active morphine sulfate may have been produced. The recalled lots were distributed under an “ETHEX” label between June 2006 and May 2008.

Lot numbers involved in the June 2008 recall:

• Morphine Sulfate ER 30 mg Tablet/NDC #58177-320-04:
  
• Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284.  The 30 mg product is a pink oval tablet with “30” on one side and “E” on the reverse.
  
• Morphine Sulfate ER 60 mg 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.  The 60 mg product is a white oval tablet with “60” on one side, and “E” on the other side.
  

Side Effects Associated with Double-Strength Morphine Sulfate Tablets

Side effects linked to ingestion of oversized or double-strength tablets include:

• Respiratory Depression (difficulty or lack of breathing)
• Low blood pressure
• Death 

According to the FDA, 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.

Consumers are advised to contact their health care providers if they have any medical questions regarding the recalled Morphine Sulfate tablets. Do not discontinue any medication without first consulting your doctor.

Note - Do not change medications without first consulting your doctor.

Please fill out the form below to contact a Case Manager.

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