Tablet Mix-Up Prompts Class I Recall

Golden State Medical Supply (GSMS) Inc is recalling a single lot of atenolol tablets after receiving a report that a bottle from the lot mistakenly contained clopidogrel. According to the November 2, 2022, US Food and Drug Administration (FDA) Enforcement Report, the recall has been designated Class I, which warns use of the affected product could cause serious adverse health consequences or death.

The recall affects atenolol tablets, 25 mg, in 1000-count bottles (NDC 60429-027-10), from lot GS046745 (Exp. 12/23). The product was manufactured by Alphapharm, marketed by Golden State Medical Supply, Camarillo, CA, and distributed throughout the United States.

“The lot under GSMS Inc’s voluntary 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 Inc,” GSMS stated in a September 29, 2022, company announcement. “They are also instructed to provide their customers, ie pharmacies and consumers, a copy of GSMS Inc’s recall notification, recall response form, and letter to consumers, patients, and caregivers.”

GSMS voluntarily initiated the recall September 29, 2022. The FDA designated the recall Class I on October 21, 2022.

Atenolol is a prescription beta blocker indicated for the treatment of hypertension. Clopidogrel is a prescription blood thinner used to lower the risk of stroke, blood clot, or serious heart problem in patients who have had a heart attack, severe chest pain, or circulation problems.

“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,” wrote GSMS. “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.”