TOPIC: Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets by Golden State Medical Supply: Recall - Due to a Label Mix-up
AUDIENCE: Patience, Health Professional, Pharmacy, Cardiology
ISSUE: Golden State Medical Supply (GSMS) is recalling Clopidogrel 75mg Tablets produced with lot# GS046745 that was mislabeled as Atenolol 25mg Tablets. This recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS are impacted. Both products are being recalled out of abundance of caution.
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, myocardial infarction), hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta 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.
To date, GSMS has not received any reports of adverse events related to the use of the products as part of this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling.
RECOMMENDATIONS: The lot# GS046745 under GSMS recall has been primarily sold to AmerisourceBergen, and McKesson.
- AmerisourceBergen and McKesson are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS. They are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS recall notification, recall response form, and letter to consumers, patients, and caregivers.
- Consumers with questions regarding this recall can contact the company.
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