Golden State Medical Supply, Inc. Issues National Voluntary Recall of Atenolol 25mg and Clopidogrel 75mg Tablets Due to Label Error

Summary

Company announcement date:
FDA Publication Date:
Type of product:
Drugs

Reason for posting:

Description of the reason for the recall

Due to label confusion

Company Name:
Golden State Medical Supply, Incorporated
Mark:

brand names)

Golden State Medical Supply, Incorporated

Product Description:

Product Description

Clopidogrel 75mg Tablets, Atenolol 25mg Tablets


company announcement

FOR IMMEDIATE RELEASE – SEPTEMBER 29, 2022 Golden State Medical Supply, Incorporated (GSMS, Inc.) – Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report has been received that a bottle containing Clopidogrel 75mg tablets produced with lot # GS046745 has been mislabeled as Clopidogrel tablets. atenolol 25 mg. This voluntary recall only affects products with lot # GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of caution.

Product Description CDN GSMS Plot # Expiration date
Clopidogrel 75 mg tablets, bottle of 1000 units 51407-032-10 GS046745 12/2023
Atenolol tablets 25mg, 1000 unit bottle 60429-027-10 GS046745 12/2023

Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to reduce the risk of a stroke, blood clot, or serious heart problem in patients who have had a heart attack, severe chest pain, or circulation problems, as directed on the product label . For more drug label information about clopidogrel bisulfate, visit: DailyMed – CLOPIDOGREL – clopidogrel bisulfate film-coated tablet (nih.gov). For more drug label information about Atenolol, visit: DailyMed – ATENOLOL Tablet (nih.gov)

Patients who abruptly stop taking atenolol, as would occur if clopidogrel were misplaced in the vial labeled with atenolol, are at increased risk of ischemic (angina, myocardial infarction), hypertensive, and arrhythmia-related adverse events. to rapid termination of beta antagonism. Additionally, patients on atenolol frequently take concomitant anticoagulants and antiplatelets and would be at increased risk of bleeding if clopidogrel was added to the regimen. To date, GSMS, Inc. has not received any reports of adverse events related to the use of products in connection with this recall.

The batch subject to GSMS, Inc.’s voluntary recall was primarily sold to AmerisourceBergen and McKesson. AmerisourceBergen and McKesson are responsible for immediately stopping distribution, quarantining all remaining product under their control, and returning recalled product to GSMS, Inc. They are also responsible for providing their customers, i.e. tell pharmacies and consumers, a copy of the GSMS, Inc. recall notification, recall response form, and letter to consumers, patients, and caregivers.

Consumers with questions regarding this recall may contact GSMS, Inc, by:
Telephone: (800) 284-8633 ext. 116 (includes days between 7:30 a.m. and 4:00 p.m. Pacific)

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.

This recall is being conducted with the knowledge of the United States Food and Drug Administration.


Company details

Consumers:
GSMS, Inc.


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