Propafenone HCI Tablets

Ethex Recalls Specific Lots of Potentially Oversized Propafenone HCI Tablets 

November 7, 2008--ETHEX Corporation of St. Louis, MO has voluntarily recalled specific lots of Propafenone HCI Tablets (150, 225, and 300 mg) due to the possibility that oversized pills containing twice the appropriate dose may have been manufactured and commercially released. 

Propafenone HCI is a prescription antiarrhythmic drug that is used to treat patients with abnormal heart rhythms. Side effects associated with an overdose of Propafenone HCI are worsening arrhythmias (irregular heartbeat) and low blood pressure. 

The following lot numbers are involved in this recall:

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

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

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

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