Hydromorphone HCI

Ethex Recalls Single Lot of Potentially Oversized Hydromorphone Tablets

December 23, 2008—Following the report of an oversize tablet, Ethex Corporation has voluntarily recalled to the consumer level a single lot of generic Hydromorphone HCI 2 mg tablets due to the possibility that oversized tablets containing double the appropriate dose may have been manufactured and commercially released.   

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

Several other Ethex drug products have been recalled this year due to the possible manufacture of oversized, double-strength tablets. Most recently, in November 2008 Ethex recalled specific lots of four other generic/non-branded products it manufactures due to the similar potential for oversized tablets: Morphine Sulfate Extended Release and Immediate Release 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.

Lot Number Involved in the Recall:

• Hydromorphone HCI Tablet, 2 mg:  Lot # 90219, with an expiration date of 3/2010.  NDC #58177-0620-04.  Hydromorphone HCI 2 mg tablets marketed by Ethex are a blue, round tablet with a script “E” on one side and a “2” on the other side, and packaged in 100-count bottles.
  

Side Effects Associated with Double-Strength Hydromorphone Tablets

According to the FDA, ingestion of a higher than expected dose of Hydromorphone may increase the risk of adverse effects associated with the drug, including:

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

Ethex Parent Company to Suspend Shipment of all Drug Products in Tablet Form

December 23, 2008—KV Pharmaceutical, parent company of Ethex Corporation, announced that, effective midnight of December 19, 2008, it is suspending shipments of all of its FDA-approved drug products in tablet form. Ethex tablets affected by suspended shipments include:  Benazepril HCI Tablets, Buspirone HCI Tablets, Dextroamphetamine Sulfate Tablets , Doxazosin Mesylate Tablets, Hydromorphone HCI Immediate Release Tablets, Isosorbide Mononitrate Extended-Release Tablets , Metoprolol Succinate Extended Release Tablets, Morphine Sulfate Extended Release Tablets , Ondansetron Orally Disintegrating Tablets, Oxycodone HCI Tablets, Potassium Chloride 20 mEq Extended-Release Tablets, and Propafenone HCI Tablets . 

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

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