FDA Recall: Morphine Sulfate 60 mg Extended Release Tablets – Recall of a Single Lot

PRESS RELEASE:

Morphine Sulfate 60 mg Extended Release Tablets – Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness

ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate.

The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008.

Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. 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. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

Read the MedWatch 2008 safety summary, including a link to the firm’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine

SOURCE: MEDWATCH

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