Drug Safety Alerts

Tetracycline HCl Capsules Consumer-Level Recall

4/16/2020

On April 16, 2020, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of Tetracycline HCl 250 mg and 500 mg capsules manufactured by Avet Pharmaceuticals, Inc. This recall was issued due to low out of specification dissolution test results.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

A list of the affected products and lot numbers is provided here.

Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, inadequate levels of tetracycline in the body may result in rapid progression of the infection and death. To date, Avet has advised that it has not received adverse event reports or complaints related to this event.

Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, as adjunctive therapy in severe acne. The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors Nationwide in United States between August 2019 and March 2020.

Avet is notifying its distributors and customers by a separate notification to distributors and through Qualanex and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Tetracycline HCl 250 mg and/or 500 mg capsules to contact their prescriber.

For more information about this recall, contact Qualanex at 1-888-424-4341, Monday through Friday, 8:00 AM to 5:00 PM (ET). You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.