FDA Recalls Morphine Sulphate Tablets For Overdose Risk

Scott Kappes

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Today the FDA and ETHEX Corporation issued a voluntary recall of a single lot of morphine sulphate tablets after a report suggested that some of the tablets were twice the appropriate thickness and therefore pose an overdose risk. The affected tablets contain twice the appropriate amount of the active ingredient, morphine sulphate. The recalled lot (Lot No. 91762) was distributed by ETHEX under the ETHEX label between April 16 and 27 of this year.

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.