Another Ethex recall: 2 Mg Hydromorphone

On December 23, 2008 Ethex Corporation recalled one lot of 2 mg hydromorphone tablets because it may contain oversized pills.

Hydromorphone is used to manage pain.  Too high a dose could cause difficulty breathing, excessive sedation, or low blood pressure.  Patients taking hydromorphone who experience these adverse effects should contact their doctor immediately.  If the patient cannot breathe or doesn’t respond, call 911.

The lot recalled is #90219.  The round tablets are blue with a script “E” on one side and a “2” on the other side.  Hydromorphone is also marketed by Abbott with the brandname Dilaudid®

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472 or fax to ETHEX Customer Service at 314-646-3751, or e-mail to customer-service@ethex.com.

On December 19 KV Pharmaceuticals, the parent company of Ethex, voluntarily suspended all shipments of tablet medications to review manufacturing and quality concerns.

David Van Vliet, newly appointed KV Pharmaceutical Interim CEO, said,

I want to reassure patients, physicians, pharmacists, and care-givers that we are committed to providing them with safe and effective products. The company’s new leadership team is taking immediate action to identify all practices and processes that can be enhanced to improve the efficiency and consistency of the company’s manufacturing.

KV has released a list of tablets that are affected by the shipping suspension.

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