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Avet Pharmaceuticals recalls Tetracycline HCl capsules

The medication has low out of specification dissolution test results

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Photo source:FDA
Avet Pharmaceuticals of East Brunswick, N.J., is recalling 100-count bottles of Tetracycline HCl capsules.

The medication has low out of specification dissolution test results, which results in less tetracycline available in the body to fight infection. This can lead to treatment failures.

The firm has not received any adverse event reports or complaints.

The following products, distributed under the Heritage Pharmaceuticals label, are being recalled:

ProductNDC NumberLot NoExpiry Date
Tetracycline HCl Capsules 250 mg 100 count23155-017-01H190666JUL 2022
Tetracycline HCl Capsules 500 mg 100 count23155-018-01G190609JUN 2022
Tetracycline HCl Capsules 500 mg 100 count23155-018-01G190610JUN 2022
Tetracycline HCl Capsules 500 mg 100 count23155-018-01G190611JUN 2022
Tetracycline HCl Capsules 500 mg 100 count23155-018-01L191027NOV 2022
Tetracycline HCl Capsules 500 mg 100 count23155-018-01L191028NOV 2022
Tetracycline HCl Capsules 500 mg 100 count23155-018-01K190953OCT 2022
Tetracycline HCl Capsules 500 mg 100 count23155-018-01K190952OCT 2022

The recalled products, used for 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, were distributed to wholesalers and distributors throughout the U.S. from between August 2019 – March 2020.

What to do

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.

Consumers with questions may contact Qualanex at (888) 424-4341. Monday – Friday, 8:00 am – 5:00 pm, (EST) or by email at recall@qualanex.com.

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