March 24, 2020

Avet Pharmaceuticals has issued a voluntary recall of eight lots of Tetracycline HCl Capsules USP, 250mg and 500mg, 100-count bottles. The medication, which is manufactured by Avet and distributed under the Heritage Pharmaceuticals label, had low dissolution results during testing.

Dissolution in this instance refers to how much drug becomes available in the body to fight infection. The tetracycline in the affected lots did not make enough of the antibiotic available, which could lead to failed treatment of infections. This presents a danger to certain patients being treated with tetracycline for an infection. In particular, treatment failure could lead to death in patients fighting a serious infection or who have compromised immune systems. As of the date of the recall, no adverse events had been reported involving the recalled product.

Tetracycline is indicated to treat infections caused by susceptible strains of specific microorganisms. These infections include upper and lower respiratory infections, skin and soft tissues infections, and infections caused by Rickettsiae, a group of bacteria responsible for diseases such as Rocky Mountain spotted fever and typhus fever. Tetracycline can also be used as an adjunctive therapy for severe acne.

Patients who may be in possession of the recalled tetracycline should contact their healthcare provider for guidance and a potential change of treatment before stopping the medication. Questions regarding the recall can be directed to Qualanex at 1-888-424-4341 or recall@qualanex.com. Anyone who has experienced problems that may be related to using the recalled product should contact their healthcare provider. Adverse effects can also be reported to the U.S. FDA’s MedWatch program.

A full list of affected lots can be found, along with additional recall information, on the FDA’s website.

There is no member impact through Benecard Central Fill.

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