Request Legal Help Now - Free

Advertisement
LAWSUITS NEWS & LEGAL INFORMATION

FDA Issues Warning for Morphine Sulfate Oral Solution 100 mg per 5 mL


Washington, DC: Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The approval of this product is part of FDA's unapproved drugs initiative. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors.

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.

Legal Help

If you or a loved one has suffered illness or an adverse health event resulting from the use of this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Jan-10-11


ADD YOUR COMMENT ON THIS ISSUE

Please read our comment guidelines before posting.


Note: Your name will be published with your comment.


Your email will only be used if a response is needed.

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.

Request Legal Help Now! - Free