Golden State Medical Supply has issued a voluntary nationwide recall of two (2) lots of Atenolol Tablets USP, 25 mg, and Clopidogrel Tablets USP, 75 mg. This is due to a labeling mix-up where the bottles labeled as containing Atenolol Tablets actually contain Clopidogrel tablets and vice versa.
The recall affects only products with lot numbers GS046745 and not any other Clopidogrel or Atenolol products marketed by GSMS. The voluntary recall is made out of an abundance of caution.
The affected product lots are:
Product 1:
Clopidogrel 75mg Tablets, 1,000 Count Bottle
GSMS NDC: 51407-032-10
LOT Numbers: GS046745
Expiration Date: 12/2023
Product 2:
Atenolol 25mg Tablets, 1,000 Count Bottle
GSMS NDC: 60429-027-10
LOT Numbers: GS046745
Expiration Date: 12/2023
Atenolol tablets are used to treat hypertension and angina, while Clopidogrel tablets are used to prevent blood clots after a recent heart attack or stroke.
Misplacing clopidogrel in the atenolol-labeled bottle will mean that patients who were taking clopidogrel will interrupt their therapy.
A sudden stop of clopidogrel therapy can lead to serious cardiovascular events such as hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. It can also cause an increased risk for ischemic (angina, myocardial infarction).
Atenolol tablets placed in the clopidogrel-labeled bottle could be taken by patients with a history of asthma or another bronchospastic disease, which would lead to exacerbation of symptoms. This will also expose them to an increased risk of bleeding if they add clopidogrel to their treatment regime.
The affected lot numbers were sold to AmerisourceBergen and McKesson. AmerisourceBergen and McKesson are advised to immediately remove the affected lot numbers from their inventory and quarantine them. They are also urged to share this notice with all appropriate personnel, including pharmacists and customers who have bought the affected product.
Patients who have the lot numbers GSMS should immediately discontinue the use of the affected tablets and contact their physician for advice. Please contact your pharmacist or healthcare provider for instructions on how to return the product.
Consumers who have questions may contact GSMS, Inc, at (800) 284-8633, ext. 116, Monday through Friday, 7:30 AM to 4:00 PM, Pacific time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Online: www.fda.gov/medwatch/report.htm
Regular Mail: use the mailing address found at www.fda.gov/MedWatch/contact.htm
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
