Beta Blocker Recall
Certain lots of atenolol tablets, USP, 50 mg, are being voluntarily recalled by two different companies, as reported in a recent US Food and Drug Administration (FDA) Enforcement Report.
The recalls, both of which are ongoing, were launched due to a customer complaint that a bottle of atenolol tablets, USP, 50 mg, contained a paroxetine 20-mg tablet. Paroxetine is an antidepressant.
Legacy Pharmaceutical Packaging, LLC, initiated 48,012 30-count bottles of atenolol tablets, USP, 50 mg, on March 7, 2017. The impacted bottles are from lot number 161901 (expiration date 04/18, NDC 68645-493-54). The recalled product was “shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA,” according to the FDA Report.
The other recall was initiated by Zydus Pharmaceuticals USA Inc on March 6, 2017, and includes both 100-count and 1000-count bottles of atenolol tablets, USP, 50 mg. A total of 9561 bottles are included in this recall. The impacted 100-count bottles are from lot number Z600724 (expiration date 04/18, NDC 68382-023-01) and the recalled 1000-count bottles are from lot number Z600725 (expiration date 04/18, NDC 68382-023-10). The affected lots were distributed in the United States and in Puerto Rico.
Atenolol is used to treat hypertension (with or without other antihypertensive agents), for the long-term management of individuals with angina pectoris, and to lower cardiovascular mortality in hemodynamically stable individuals with acute myocardial infarction.
The recalled 30-count bottles were distributed by The Kroger Company in Cincinnati, OH, manufactured for Zydus Pharmaceuticals USA Inc. in Pennington, NJ, and packaged by Legacy Pharmaceutical Packaging, LLC, in Earth City, MO. The recalled 100-count and 1000-count bottles were manufactured by Cadila Healthcare Ltd. in India and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.
The FDA classified both recalls as Class II on March 21, 2017.
-Meredith Edwards White
