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Oversized Morphine Tablets Recalled Legal Evaluation

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Oversized Morphine Tablets Recalled

June 2008

Morphine tablets recalled A recall has been announced for certain lots of morphine tablets that can pose a health risk to patients. ETHEX Corporation initiated the recall after oversized tablets were found in previously recalled lots of the medication.

The oversized tablets may contain twice the amount of active ingredient that the drug label indicates. The recall affects certain lots of morphine sulfate 60 mg extended release tablets as well as lots of 30 mg extended release tablets. The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label from June 2006 to May 2008.

If taken in dangerous doses, medications such as morphine can have life-threatening side effects that include respiratory depression (difficulty or lack of breathing), hypotension, low blood pressure, and apnea. The recalled 60 mg morphine tablet is a white oval with “60” on one side and “E” on the reverse. The 30 mg table is a pink oval with “30” on one side and “E” on the reverse.

Source: "ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets NDC #58177-320-04 & 58177-330-04 Lot Numbers listed below." FDA Press Release. June 13, 2008.

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