Recall: Antipsychotic Found in Bottle Labeled for GERD Medication
AstraZeneca announced a voluntary recall of 34,524 bottles of Nexium (esomeprazole magnesium) delayed-release capsules following the discovery of a bottle containing Seroquel XR (quetiapine fumarate) extended-release tablets instead.
The recall was due to a confirmed customer complaint by a retail pharmacist who found Seroquel XR tablets in an unopened bottle labeled as Nexium. The affected Nexium 20mg 30-count bottles have the lot #FC0064 with an expiration date of 5/2017.
The Food and Drug Administration (FDA) has designated this as a Class II product recall.
Nexium is a proton pump inhibitor indicated for the treatment of GERD and erosive esophagitis, and as part of triple therapy for H. pylori eradication. Seroquel XR, an antipsychotic agent, is used to treat bipolar disorder, major depressive disorder, and schizophrenia.
Healthcare providers are to report any adverse outcomes related to this medication switch via local reporting mechanisms.
For more information call (888) 463-6332 or visit FDA.gov.