Sandoz recalls Losartan Potassium, Ezetimibe drug bottles in US over packaging issue

New Delhi: Sandoz Inc. recently announced a voluntary recall and corrective action notice for particular lots of Losartan Potassium and Ezetimibe prescription drug bottles distributed in the U.S. as the cap and bottle combination does not meet federal standards for child-resistant packaging, posing a risk of harm if the tablets are swallowed by children.

The prescription drug packaging is not child-resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children. However, there are no quality or safety issues with the medicines for their intended use.

This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe from Sandoz with certain lot numbers. The recalled bottles have "Sandoz," the name of the medication, dosage, and NDC on the front of the bottle labels and the lot number and expiration date on the side of the bottle labels. Clinics and pharmacies sold the drug nationwide as a prescribed medicine from July 2018 through August 2019.

The products affected by the recall and corrective action notice include production lots of the following medicines that have been distributed by Sandoz in the U.S. to date:

Ezetimibe: 10mg tablets in 30 and 90 count bottles. The only affected National Drug Code (NDC) numbers are # 0781-5690-31 (30 tablets) and # 0781-5690-92 (90 tablets).

Losartan Potassium: 50mg in 30 count bottles. The affected NDC number is # 0781-5701-31.

Consumers are directed by the firm to immediately secure the medications to keep them out of the sight and reach of children and contact Sandoz for a free replacement child-resistant bottle cap. Once the medication is secured, consumers can continue to use the medication as directed.

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