FDA Recall Announced for Atenolol, Clopidogrel based on Labeling Mix-up

The US Food and Drug Administration (FDA) announced Thursday, September 29, that Golden State Medical Supply (GSMS) is voluntarily recalling 2 common cardiovascular medications due to a labeling issue.

The medications involved are the ß-blocker atenolol, prescribed to reduce hypertension, and the antiplatelet agent clopidogrel, which reduces the risk of acute myocardial infarction (AMI) or stroke among patients with a history of AMI, angina, or peripheral arterial disease.

GSMS notified the FDA that a bottle containing 75-mg tablets of clopidogrel was accidentally given the label for 25-mg atenolol tablets. Only one lot of each medication—lot #GS046745—was affected by this mix-up. Both lots expire are set to expire in December 2023.

“No other clopidogrel or atenolol products marketed by GSMS are impacted,” according to the company’s advisory posted to the FDA’s website. “Both products are being recalled out of abundance of caution.”

According to GSMS, of Camarillo, CA, the company has received no reports of adverse events related to this issue, but the FDA advisory highlights some potential risks for patients, as follows:

“Patients who suddenly stop taking atenolol, as would happen if clopidogrel were misplaced in the atenolol-labeled bottle, are at increased risk for ischemic (angina, MI), hypertensive, and arrhythmic adverse events relating to rapid withdrawal of ß-antagonism.

“Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen.”

“No other clopidogrel or atenolol products marketed by GSMS are impacted. Both products are being recalled out of abundance of caution.”

The lot being voluntarily recalled has been primarily sold to 2 GSMS customers, AmerisourceBergen and McKesson. Both companies have been instructed to “immediately stop distribution, quarantine all remaining products in their control and return the recalled product to GSMS.” Further, the 2 distributors have been instructed to provide their own customers (pharmacies, consumers) a copy of the GSMS Inc recall notice, a recall response form, and a letter to provide to consumers, patients, and caregivers.

Any adverse reactions believed to be associated with this issue can be reported to the FDA’s MedWatch Adverse Event Reporting Program. They can be submitted online or by mailing in this form.